Open dataset · Weekly (Wednesdays); same-day entries for warning-letter waves and court rulings
FDA Peptide and GLP-1 Enforcement Tracker
201 events from January 2025 to 2026-09-01, 189 of them linked to the primary document. Warning letters by wave, PCAC votes by peptide, docket numbers, and a weekly change log.
Key findings from FormBlends Research
FormBlends Research finding 1
#FDA issued 81 warning letters touching peptides, GLP-1 drugs or telehealth sellers in 2026 through 2026-09-01, against 83 in all of 2025, according to FDA's warning-letter database.
FormBlends Research finding 2
#The letters arrive in waves: 61 rows on 09/09/2025 (including Hims & Hers), 30 letters announced 03/03/2026, 25 telehealth letters on 06/15-16/2026, and five research-peptide vendors dated 08/24/2026 and posted 09/01/2026.
FormBlends Research finding 3
#On 08/27/2026 the Fifth Circuit affirmed FDA in both GLP-1 shortage cases (Nos. 25-10600 tirzepatide and 25-10758 semaglutide), holding the agency's shortage-resolution determinations were not arbitrary and capricious. The compounding exceptions tied to the shortages ended 12/19/2024 (tirzepatide) and 02/21/2025 (semaglutide).
FormBlends Research finding 4
#FDA's GLP-1 concerns page, current as of 09/01/2026, reports 990 adverse-event reports for compounded semaglutide and more than 730 for compounded tirzepatide as of 05/31/2026, and states that retatrutide and cagrilintide cannot be compounded under federal law.
FormBlends Research finding 5
#Twelve peptides including BPC-157, TB-500 and MOTS-c left FDA's Category 2 list in April 2026 when their nominations were withdrawn; PCAC voted to recommend six of them on 07/23-24/2026. None is on the 503A bulks list yet, so none is lawfully compoundable until FDA issues a rule.
FormBlends Research finding 6
#FDA proposed on 04/30/2026 to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list; the comment period was extended on 06/26/2026 and no final rule had issued by the tracker date.
The data
| Date | Type | Event | Who | Summary | Source | Source type | Date precision |
|---|---|---|---|---|---|---|---|
| 2026-09-01 | Adverse-event report update | FDA GLP-1 concerns page updated: 990 adverse-event reports for compounded semaglutide and >730 for compounded tirzepatide (as of May 31, 2026); border screening and fake-pharmacy labels | FDA, semaglutide, tirzepatide, retatrutide, cagrilintide | Page 'Content current as of 09/01/2026'. Also states retatrutide and cagrilintide cannot be used in compounding under federal law; salt forms (semaglutide sodium/acetate) should not be used; green-list Import Alert 66-80 for GLP-1 APIs; fraudulent compounded products naming pharmacies that do not exist; one AE report tied to such a product. | fda.gov/drugs/postmarket-drug-safety-information-patients-an... | primary | day |
| 2026-08-28 | Label or price event | FDA approves Mounjaro (tirzepatide) to reduce MACE risk in adults with type 2 diabetes (SURPASS-CVOT) | FDA, Eli Lilly, Mounjaro, tirzepatide | Lilly press release Aug 28, 2026; non-inferior to dulaglutide with 8% lower MACE rate; >13,000 participants. | investor.lilly.com/news-releases/news-release-details/fda-ap... | primary | day |
| 2026-08-27 | Court decision | Fifth Circuit affirms summary judgment for FDA in both GLP-1 shortage cases (Nos. 25-10600 tirzepatide; 25-10758 semaglutide) | Fifth Circuit, OFA, FDA, Eli Lilly, Novo Nordisk, tirzepatide, semaglutide | Per curiam, unpublished (Richman, Duncan, Oldham). Holding: FDA's declaratory orders resolving the tirzepatide (Dec 19, 2024) and semaglutide (Feb 21, 2025) shortages were not arbitrary and capricious; district court judgments (N.D. Tex. 4:24-cv-953 and 4:25-cv-174) AFFIRMED. Semaglutide opinion revised 09/01/2026: https://www.ca5.uscourts.gov/opinions/unpub/25/25-10758.0.pdf | ca5.uscourts.gov/opinions/unpub/25/25-10600.0.pdf | primary | day |
| 2026-08-24 | FDA warning letter | FDA warning letters to five peptide vendors: Peak Performance Peptides (735127), Royal Peptides (734884), NuScience Peptides (733652), Peptide Partners (735063), TXP Innovations dba Tex Peptides (735067) | FDA, Peak Performance Peptides, Royal Peptides, NuScience Peptides, Peptide Partners, Tex Peptides, semaglutide, tirzepatide, retatrutide, tesamorelin, PT-141 | Posted 09/01/2026; CDER Office of Unapproved Drugs and Labeling Compliance; products include semaglutide, tirzepatide, retatrutide and other peptides (Peptide Partners letter also cites tesamorelin, bremelanotide, elamipretide per ArgusHQ summary); 'research use only' disclaimers rejected in footnote. | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-08-24 | FDA warning letter | FDA warning letter: TXP Innovations LLC dba Tex Peptides (Unapproved New Drugs/Misbranded) | FDA, TXP Innovations LLC dba Tex Peptides, peptide | Issued 08/24/2026, posted 09/01/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-08-24 | FDA warning letter | FDA warning letter: Royal Peptides LLC (Unapproved New Drugs/Misbranded) | FDA, Royal Peptides LLC, peptide | Issued 08/24/2026, posted 09/01/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-08-24 | FDA warning letter | FDA warning letter: NuScience Peptides LLC (Unapproved New Drugs/Misbranded) | FDA, NuScience Peptides LLC, peptide | Issued 08/24/2026, posted 09/01/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-08-24 | FDA warning letter | FDA warning letter: Peptide Partners LLC (Unapproved New Drugs/Misbranded) | FDA, Peptide Partners LLC, peptide | Issued 08/24/2026, posted 09/01/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-08-24 | FDA warning letter | FDA warning letter: Peak Performance Peptides (Unapproved New Drugs/Misbranded) | FDA, Peak Performance Peptides, peptide | Issued 08/24/2026, posted 09/01/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-07-29 | FTC action | FTC, Utah and Los Angeles County sue Hims & Hers over health-data sharing with ad platforms, pre-consult charging and cancellation friction | FTC, Hims & Hers, Utah, Los Angeles County | Complaint filed in N.D. Cal.; alleges sharing health data with Meta, Snap and others via customer lists and pixels; shares fell ~12%. | ftc.gov/news-events/news/press-releases/2026/07/ftc-states-a... | primary | day |
| 2026-07-27 | PCAC advisory committee | FDA announces second peptide PCAC meeting before end of February 2027 (LL-37, GHK-Cu, Dihexa acetate, Melanotan II, PEG-MGF) | FDA, PCAC, LL-37, GHK-Cu, Dihexa, Melanotan II, PEG-MGF | FDA page: 'FDA will host an advisory committee meeting before the end of February 2027'; FR notice and docket not yet published. Substance list per FDA 503A PDF (GHK-Cu) and industry summaries; announcement date per Restorative Compounding blog. | fda.gov/advisory-committees/pharmacy-compounding-advisory-co... | primary | approximate |
| 2026-07-24 | PCAC advisory committee | PCAC recommends Epitalon (7-4-1) and Semax (8-5-1); votes against Emideltide (DSIP) | FDA, PCAC, Epitalon, Semax, Emideltide | Day 2 outcomes per McDermott/NCPA/Olympia summaries; FDA has not yet published a decision or proposed rule. | fda.gov/advisory-committees/advisory-committee-calendar/july... | primary | day |
| 2026-07-23 | PCAC advisory committee | PCAC votes to recommend BPC-157, KPV, TB-500 (each 8-6-1) and MOTS-c (7-5-2) for the 503A bulks list, against FDA staff recommendation | FDA, PCAC, BPC-157, KPV, TB-500, MOTS-c | Vote tallies per McDermott and Olympia Pharmacy write-ups; FDA meeting page (current 08/06/2026) hosts briefing documents (FDA staff recommended against all four). Non-binding; rulemaking required before any compounding is lawful. | fda.gov/advisory-committees/advisory-committee-calendar/july... | primary | day |
| 2026-07-09 | Lawsuit | EVEXIAS Life Sciences publicizes legal challenge to FDA Category 2 placement of 17 peptides | Evexias, Farmakeio, FDA | FOX 26 Houston report published Jul 9, 2026. Background: Evexias Medical Centers et al v. FDA, N.D. Tex. 4:24-cv-00293 (APA), settled Sept 2024 requiring PCAC review (APC). Status of any 2026 filing not verified in a court record. | fox26houston.com/morning-show/peptide-court-battle-fda-restr... | secondary | day |
| 2026-06-26 | FDA policy or guidance | FDA extends comment period on proposal to exclude semaglutide/tirzepatide/liraglutide from 503B bulks list | FDA, 503B, semaglutide, tirzepatide | Federal Register notice extending the May 1, 2026 comment period. | federalregister.gov/documents/2026/06/26/2026-12937/list-of-... | primary | day |
| 2026-06-23 | FDA warning letter | FDA warning letter: Buy Keta Online / www.buyketaonline.com (Unapproved New Drugs/Misbranded) | FDA, Buy Keta Online / www.buyketaonline.com | Issued 06/23/2026, posted 07/07/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-06-23 | FDA warning letter | FDA warning letter: Ketamine Troche Store / www.ketaminetrochestore.com (Unapproved New Drugs/Misbranded) | FDA, Ketamine Troche Store / www.ketaminetrochestore.com | Issued 06/23/2026, posted 07/07/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-06-23 | FDA warning letter | FDA warning letter: Ketamine Store / www.ketaminestore.org (Unapproved New Drugs/Misbranded) | FDA, Ketamine Store / www.ketaminestore.org | Issued 06/23/2026, posted 07/07/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-06-17 | FDA warning letter | FDA warning letter: Wholesale Peptide (Unapproved New Drugs/Misbranded) | FDA, Wholesale Peptide, peptide | Issued 06/17/2026, posted 06/23/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-06-15 | FDA warning letter | FDA issues 25 warning letters to telehealth companies over compounded GLP-1 promotion (third wave) | FDA, telehealth, semaglutide, tirzepatide | FDA telehealth guidance page current as of 06/15/2026; FDA social post Jun 16, 2026; 29 relevant June-2026 letters in FDA database. Sheppard Mullin notes FDA cited >1,700 adverse events for compounded semaglutide/tirzepatide as of May 21, 2026. | fda.gov/drugs/human-drug-compounding/fda-telehealth-companie... | primary | day |
| 2026-06-08 | FDA warning letter | FDA warning letter: Trinity HealthCare Supply, LLC dba altRx (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Trinity HealthCare Supply, LLC dba altRx, telehealth | Issued 06/08/2026, posted 06/16/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-06-08 | FDA warning letter | FDA warning letter: Momentum Health 360 dba Momentum Health (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Momentum Health 360 dba Momentum Health, telehealth | Issued 06/08/2026, posted 06/16/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-06-08 | FDA warning letter | FDA warning letter: Maximus Health, Inc. dba Maximus (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Maximus Health, Inc. dba Maximus, telehealth | Issued 06/08/2026, posted 06/16/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-06-08 | FDA warning letter | FDA warning letter: Glow Medispa, LLC dba Mint Med (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Glow Medispa, LLC dba Mint Med, telehealth | Issued 06/08/2026, posted 06/16/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-06-08 | FDA warning letter | FDA warning letter: Ezra Holdco LLC dba Ezra (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Ezra Holdco LLC dba Ezra, telehealth | Issued 06/08/2026, posted 06/16/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-06-08 | FDA warning letter | FDA warning letter: Public Health Solution LLC dba DrMedHealth (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Public Health Solution LLC dba DrMedHealth, telehealth | Issued 06/08/2026, posted 06/16/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-06-08 | FDA warning letter | FDA warning letter: D&H Medical Services (False & Misleading Claims/Misbranded (Telehealth)) | FDA, D&H Medical Services, telehealth | Issued 06/08/2026, posted 06/16/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-06-08 | FDA warning letter | FDA warning letter: Amie Health, Inc. dba Amie (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Amie Health, Inc. dba Amie, telehealth | Issued 06/08/2026, posted 06/16/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-06-08 | FDA warning letter | FDA warning letter: Altru Telehealth, LLC dba Altru Telehealth (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Altru Telehealth, LLC dba Altru Telehealth, telehealth | Issued 06/08/2026, posted 06/16/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-06-08 | FDA warning letter | FDA warning letter: Eden Health International Inc. dba Eden (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Eden Health International Inc. dba Eden, telehealth | Issued 06/08/2026, posted 06/16/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-06-08 | FDA warning letter | FDA warning letter: NativeMed LLC dba NativeMed (False & Misleading Claims/Misbranded (Telehealth)) | FDA, NativeMed LLC dba NativeMed, telehealth | Issued 06/08/2026, posted 06/16/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-06-08 | FDA warning letter | FDA warning letter: FitRX, LLC dba AM RX (False & Misleading Claims/Misbranded (Telehealth)) | FDA, FitRX, LLC dba AM RX, telehealth | Issued 06/08/2026, posted 06/16/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-06-08 | FDA warning letter | FDA warning letter: Medica Weight Loss (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Medica Weight Loss, telehealth | Issued 06/08/2026, posted 06/16/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-06-08 | FDA warning letter | FDA warning letter: Clover Meds LLC dba Clover Meds (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Clover Meds LLC dba Clover Meds, telehealth | Issued 06/08/2026, posted 06/16/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-06-08 | FDA warning letter | FDA warning letter: Nexlife Inc. dba Nexlife (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Nexlife Inc. dba Nexlife, telehealth | Issued 06/08/2026, posted 06/16/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-06-08 | FDA warning letter | FDA warning letter: Roen Health, Inc. dba RoenRx (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Roen Health, Inc. dba RoenRx, telehealth | Issued 06/08/2026, posted 06/16/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-06-08 | FDA warning letter | FDA warning letter: Joi and Blokes dba Joi + Blokes (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Joi and Blokes dba Joi + Blokes, telehealth | Issued 06/08/2026, posted 06/16/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-06-08 | FDA warning letter | FDA warning letter: VivioMD Group LLC dba VivioMD (False & Misleading Claims/Misbranded (Telehealth)) | FDA, VivioMD Group LLC dba VivioMD, telehealth | Issued 06/08/2026, posted 06/16/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-06-08 | FDA warning letter | FDA warning letter: Thrivelab Co. dba Thrivelab (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Thrivelab Co. dba Thrivelab, telehealth | Issued 06/08/2026, posted 06/16/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-06-08 | FDA warning letter | FDA warning letter: Nexus Health Solutions LLC dba Harper Meds (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Nexus Health Solutions LLC dba Harper Meds, telehealth | Issued 06/08/2026, posted 06/16/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-06-08 | FDA warning letter | FDA warning letter: Nova Vascular LLC dba NOVARX (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Nova Vascular LLC dba NOVARX, telehealth | Issued 06/08/2026, posted 06/16/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-06-08 | FDA warning letter | FDA warning letter: Ready Med (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Ready Med, telehealth | Issued 06/08/2026, posted 06/16/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-06-08 | FDA warning letter | FDA warning letter: OrderlyMeds LLC dba OrderlyMeds (False & Misleading Claims/Misbranded (Telehealth)) | FDA, OrderlyMeds LLC dba OrderlyMeds, telehealth | Issued 06/08/2026, posted 06/16/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-06-08 | FDA warning letter | FDA warning letter: HydraMed IV LLC dba HydraMed (False & Misleading Claims/Misbranded (Telehealth)) | FDA, HydraMed IV LLC dba HydraMed, telehealth | Issued 06/08/2026, posted 06/16/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-06-08 | FDA warning letter | FDA warning letter: FITISH (False & Misleading Claims/Misbranded (Telehealth)) | FDA, FITISH, telehealth | Issued 06/08/2026, posted 06/16/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-06 | State board action | Alabama Board of Medical Examiners: official notice prohibiting physicians from prescribing, compounding, administering or supplying non-FDA-approved 'research-grade' peptides | Alabama BME, BPC-157 | Notice states under no circumstances may a physician compound, administer or dispense a research-grade peptide; cannot delegate to CNMs/CRNPs/PAs; patient self-acquisition risk rests with patient. Page carries no date stamp; referenced in NABP June 2026 mailbag and Drug Topics coverage. Month approximate. | albme.gov/press-release/board-issues-official-notice-concern... | primary | approximate |
| 2026-05-14 | PCAC advisory committee | FDA updates 503A category list: GHK-Cu (non-injectable routes) restored to Category 1; PCAC on GHK-Cu before end of Feb 2027 | FDA, GHK-Cu, NAD+ | PDF 'Updated May 14, 2026': nominator clarified May 5, 2026 it withdrew only the injectable route; NAD and NADH remain in Category 1; GHRP-2/GHRP-6 in Category 3. | fda.gov/media/94155/download | primary | day |
| 2026-05-12 | FDA warning letter | FDA warning letter: Fagron BV (Compounding Pharmacy/Adulterated Drug Products) | FDA, Fagron BV | Issued 05/12/2026, posted 06/09/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-04-30 | FDA policy or guidance | FDA proposes to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list (no clinical need) | FDA, 503B, semaglutide, tirzepatide, liraglutide | Press release Apr 30, 2026; Federal Register notice May 1, 2026 (2026-08552); comment period extended Jun 26, 2026 (2026-12937). | fda.gov/news-events/press-announcements/fda-proposes-exclude... | primary | day |
| 2026-04-30 | PCAC advisory committee | PCAC charter renewed to April 25, 2028 | FDA, PCAC | Federal Register renewal notice. | federalregister.gov/documents/2026/04/30/2026-08378/advisory... | primary | day |
| 2026-04-20 | Adverse-event report update | FDA adverse-event count snapshot: >520 compounded semaglutide and >480 compounded tirzepatide reports (as of Apr 20, 2025) | FDA, semaglutide, tirzepatide | Earlier FDA-page snapshot preserved by AMWA (secondary); useful as trend baseline vs 990/>730 as of May 31, 2026. | amwa-doc.org/physician-practice-alert-compounded-glp-1-drugs... | secondary | snapshot 2025-04-20 |
| 2026-04-16 | PCAC advisory committee | Federal Register: PCAC meeting notice for July 23-24, 2026 on seven peptides; docket FDA-2025-N-6895 | FDA, PCAC, BPC-157, KPV, TB-500, MOTS-c, Emideltide, Semax, Epitalon | 91 FR 20465. Day 1: BPC-157 (UC), KPV (wound healing/inflammation), TB-500 (wound healing), MOTs-C (obesity/osteoporosis). Day 2: Emideltide (opioid withdrawal/insomnia/narcolepsy), Semax (cerebral ischemia/migraine/trigeminal neuralgia), Epitalon (insomnia). Comments due Jul 9, 2026. | federalregister.gov/documents/2026/04/16/2026-07361/pharmacy... | primary | day |
| 2026-04-15 | PCAC advisory committee | FDA announces removal of 12 peptide bulk substances from 503A Category 2 (nominations withdrawn) and schedules PCAC review | FDA, BPC-157, TB-500, KPV, MOTS-c, Epitalon, Semax, GHK-Cu, LL-37, Melanotan II | FDA Category 2 page (current as of 04/22/2026) now lists BPC-157, TB-500, KPV, MOTs-C, Epitalon, Semax, Emideltide (DSIP), injectable GHK-Cu, LL-37, Dihexa, Melanotan II, PEG-MGF under 'nominated but withdrawn' (previously Category 2). Removal effective ~Apr 22, 2026 (FDA 503A category PDF: GHK-Cu 'removed from category 1 on April 22, 2026'). Announcement date per industry counsel (Boesen & Snow; Newtropin). | fda.gov/drugs/human-drug-compounding/certain-bulk-drug-subst... | primary | approximate |
| 2026-04-07 | FDA warning letter | FDA warning letter: ProRx LLC (Compounding Pharmacy/Adulterated Drug Products) | FDA, ProRx LLC | Issued 04/07/2026, posted 05/12/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-04-01 | FDA policy or guidance | FDA reminder on 503A/503B exemption conditions for compounded GLP-1s | FDA, 503A, 503B | Dated [4/1/2026] entry on FDA's GLP-1 compounder policy page (page current as of 04/01/2026). | fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-polic... | primary | day |
| 2026-03-31 | FDA warning letter | FDA warning letter to Gram Peptides (MARCS-CMS 721806) for retatrutide and tirzepatide sold 'for research use only' | FDA, Gram Peptides, retatrutide, tirzepatide | Website reviewed Jan-Mar 2026; products: retatrutide ('GLP-1-R peptide'), tirzepatide ('GLP-2 peptide'), bacteriostatic water; unapproved new drugs and misbranded. | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-03-31 | FDA warning letter | FDA warning letter: Lovega LLC dba Pink Pony Peptides (Unapproved New Drugs Sold Over the Internet) | FDA, Lovega LLC dba Pink Pony Peptides, peptide | Issued 03/31/2026, posted 04/07/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-03-31 | FDA warning letter | FDA warning letter: Guangzhou Huli Technology Co., Ltd. dba Fantasy Face (Unapproved New Drugs Sold Over the Internet) | FDA, Guangzhou Huli Technology Co., Ltd. dba Fantasy Face | Issued 03/31/2026, posted 04/07/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-03-31 | FDA warning letter | FDA warning letter: Gram Peptides (Unapproved New Drugs Sold Over the Internet) | FDA, Gram Peptides, peptide | Issued 03/31/2026, posted 04/07/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-03-31 | FDA warning letter | FDA warning letter: Prime Sciences (Unapproved New Drugs Sold Over the Internet) | FDA, Prime Sciences | Issued 03/31/2026, posted 04/07/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-03-31 | FDA warning letter | FDA warning letter: Mile High Compounds LLC (Unapproved New Drugs Sold Over the Internet) | FDA, Mile High Compounds LLC | Issued 03/31/2026, posted 04/07/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-03-31 | FDA warning letter | FDA warning letter: PekCura Labs (Unapproved New Drugs Sold Over the Internet) | FDA, PekCura Labs | Issued 03/31/2026, posted 04/07/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-03-20 | FDA warning letter | FDA warning letter: RC Outsourcing, LLC (Compounding Pharmacy/Adulterated Drug Products) | FDA, RC Outsourcing, LLC | Issued 03/20/2026, posted 04/21/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-03-09 | Lawsuit | Novo Nordisk drops Hims patent suit; Hims to sell branded Wegovy/Ozempic and stop advertising compounded GLP-1s | Novo Nordisk, Hims & Hers | Novo reserves right to refile (PBS/Reuters Mar 9, 2026). | cnbc.com/2026/03/09/novo-nordisk-ends-legal-proceedings-hims... | secondary | day |
| 2026-03-03 | FDA warning letter | FDA announces 30 warning letters to telehealth companies for false/misleading compounded GLP-1 claims | FDA, telehealth, semaglutide, tirzepatide | Press release 03/03/2026: second group of telehealth letters; violations include implying sameness with approved drugs and branding compounded drugs with the telehealth firm's name. Letters carry Feb 2026 issue dates (32 relevant Feb-2026 rows in FDA database). | fda.gov/news-events/press-announcements/fda-warns-30-telehea... | primary | day |
| 2026-02-27 | FDA policy or guidance | HHS Secretary Kennedy says ~14 of 19 Category 2 peptides will return to compounding eligibility (Joe Rogan Experience) | HHS, RFK Jr., BPC-157, TB-500, CJC-1295, ipamorelin, GHK-Cu | Public remarks, not an FDA action; RAPS and AJMC report the statement. Formal FDA action followed Apr 15-16, 2026. | raps.org/resource/fda-considers-adding-a-dozen-peptides-to-i... | secondary | day |
| 2026-02-20 | FDA warning letter | FDA warning letter: Zeuss LLC dba Zeuss (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Zeuss LLC dba Zeuss, telehealth | Issued 02/20/2026, posted 03/03/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-02-20 | FDA warning letter | FDA warning letter: Lean Rx, Inc. dba SkinnyRx (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Lean Rx, Inc. dba SkinnyRx, telehealth | Issued 02/20/2026, posted 03/03/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-02-20 | FDA warning letter | FDA warning letter: Good Girl LLC dba GoodGirlRX (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Good Girl LLC dba GoodGirlRX, telehealth | Issued 02/20/2026, posted 03/03/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-02-20 | FDA warning letter | FDA warning letter: Kin Meds (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Kin Meds, telehealth | Issued 02/20/2026, posted 03/03/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-02-20 | FDA warning letter | FDA warning letter: Better Health Labs, Inc. dba Measured (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Better Health Labs, Inc. dba Measured, telehealth | Issued 02/20/2026, posted 03/03/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-02-20 | FDA warning letter | FDA warning letter: Premium Health Management Inc. dba Premium Health (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Premium Health Management Inc. dba Premium Health, telehealth | Issued 02/20/2026, posted 03/05/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-02-20 | FDA warning letter | FDA warning letter: Bliv Wellness LLC dba Bliv (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Bliv Wellness LLC dba Bliv, telehealth | Issued 02/20/2026, posted 03/03/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-02-20 | FDA warning letter | FDA warning letter: BluefitMD (False & Misleading Claims/Misbranded (Telehealth)) | FDA, BluefitMD, telehealth | Issued 02/20/2026, posted 03/03/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-02-20 | FDA warning letter | FDA warning letter: Deluxe IV Aesthetics PLLC dba Deluxe IV and Aesthetics (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Deluxe IV Aesthetics PLLC dba Deluxe IV and Aesthetics, telehealth | Issued 02/20/2026, posted 03/03/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-02-20 | FDA warning letter | FDA warning letter: Aspen Aesthetics dba Fifty 410 (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Aspen Aesthetics dba Fifty 410, telehealth | Issued 02/20/2026, posted 03/03/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-02-20 | FDA warning letter | FDA warning letter: FitRX, LLC dba FitRx (False & Misleading Claims/Misbranded (Telehealth)) | FDA, FitRX, LLC dba FitRx, telehealth | Issued 02/20/2026, posted 03/03/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-02-20 | FDA warning letter | FDA warning letter: Genesis Health International Inc. dba Genesis (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Genesis Health International Inc. dba Genesis, telehealth | Issued 02/20/2026, posted 03/03/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-02-20 | FDA warning letter | FDA warning letter: Kare Solutions, LLC dba Zappy (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Kare Solutions, LLC dba Zappy, telehealth | Issued 02/20/2026, posted 03/03/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-02-20 | FDA warning letter | FDA warning letter: Strut Health, LLC dba Strut (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Strut Health, LLC dba Strut, telehealth | Issued 02/20/2026, posted 03/03/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-02-20 | FDA warning letter | FDA warning letter: Refills Health, LLC dba Refills Health (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Refills Health, LLC dba Refills Health, telehealth | Issued 02/20/2026, posted 03/03/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-02-20 | FDA warning letter | FDA warning letter: Weightless Medical LLC dba WeightCare (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Weightless Medical LLC dba WeightCare, telehealth | Issued 02/20/2026, posted 03/03/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-02-20 | FDA warning letter | FDA warning letter: Viv Health, Inc. dba VIV RX (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Viv Health, Inc. dba VIV RX, telehealth | Issued 02/20/2026, posted 03/03/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-02-20 | FDA warning letter | FDA warning letter: Peaks Curative, LLC dba Peaks (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Peaks Curative, LLC dba Peaks, telehealth | Issued 02/20/2026, posted 03/03/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-02-20 | FDA warning letter | FDA warning letter: PharmaZee (False & Misleading Claims/Misbranded (Telehealth)) | FDA, PharmaZee, telehealth | Issued 02/20/2026, posted 03/03/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-02-20 | FDA warning letter | FDA warning letter: Ivim Services LLC dba Ivim (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Ivim Services LLC dba Ivim, telehealth | Issued 02/20/2026, posted 03/03/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-02-20 | FDA warning letter | FDA warning letter: Join Josie (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Join Josie, telehealth | Issued 02/20/2026, posted 03/03/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-02-20 | FDA warning letter | FDA warning letter: Levity Inc. dba Levity (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Levity Inc. dba Levity, telehealth | Issued 02/20/2026, posted 03/03/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-02-20 | FDA warning letter | FDA warning letter: MaxLife Technologies Inc. dba Maxlife (False & Misleading Claims/Misbranded (Telehealth)) | FDA, MaxLife Technologies Inc. dba Maxlife, telehealth | Issued 02/20/2026, posted 03/03/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-02-20 | FDA warning letter | FDA warning letter: MEDVi, LLC dba MEDVi (False & Misleading Claims/Misbranded (Telehealth)) | FDA, MEDVi, LLC dba MEDVi, telehealth | Issued 02/20/2026, posted 03/03/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-02-20 | FDA warning letter | FDA warning letter: Newman Clinic, PLLC dba Newman Clinic (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Newman Clinic, PLLC dba Newman Clinic, telehealth | Issued 02/20/2026, posted 03/03/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-02-20 | FDA warning letter | FDA warning letter: NewSelf Limited dba NewSelf (False & Misleading Claims/Misbranded (Telehealth)) | FDA, NewSelf Limited dba NewSelf, telehealth | Issued 02/20/2026, posted 03/03/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-02-20 | FDA warning letter | FDA warning letter: 24HrDoc, Inc. dba 24HrDoc (False & Misleading Claims/Misbranded (Telehealth)) | FDA, 24HrDoc, Inc. dba 24HrDoc, telehealth | Issued 02/20/2026, posted 03/03/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-02-20 | FDA warning letter | FDA warning letter: Alan Health Technologies Inc. dba Alan (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Alan Health Technologies Inc. dba Alan, telehealth | Issued 02/20/2026, posted 03/03/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-02-20 | FDA warning letter | FDA warning letter: Dripgym Mobile Parent, LLC dba Amp Health (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Dripgym Mobile Parent, LLC dba Amp Health, telehealth | Issued 02/20/2026, posted 03/03/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-02-20 | FDA warning letter | FDA warning letter: Belle Health LLC dba Belle (False & Misleading Claims/Misbranded (Telehealth)) | FDA, Belle Health LLC dba Belle, telehealth | Issued 02/20/2026, posted 03/03/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-02-09 | Lawsuit | Novo Nordisk sues Hims & Hers for infringing US Patent 8,129,343 (compounded semaglutide) | Novo Nordisk, Hims & Hers, semaglutide | Novo company statement Feb 9, 2026; first US patent case by Novo against a compounder/telehealth seller; seeks permanent ban and damages. | novomedlink.com/content/dam/novomedlink/semaglutide/02-09-20... | primary | day |
| 2026-02-09 | FDA warning letter | FDA warning letter: Thrive Health and Wellness, LLC dba Thrive Health Solutions (Compounding Pharmacy/Adulterated Drug Products) | FDA, Thrive Health and Wellness, LLC dba Thrive Health Solutions | Issued 02/09/2026, posted 04/21/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-02-06 | FDA policy or guidance | FDA announces intent to restrict GLP-1 APIs for mass-marketed compounded drugs; HHS refers Hims & Hers to DOJ | FDA, HHS, Hims & Hers, semaglutide | FDA press release (02/06/2026) names Hims & Hers after its $49 compounded GLP-1 pill launch; states companies cannot claim compounded products are generic/same as approved drugs. HHS General Counsel announced DOJ referral same day (CNBC/Politico). | fda.gov/news-events/press-announcements/fda-intends-take-act... | primary | day |
| 2026-02-02 | FDA warning letter | FDA warning letter: Apollo Care, LLC (Compounding Pharmacy/Adulterated Drug Products) | FDA, Apollo Care, LLC | Issued 02/02/2026, posted 04/21/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-01-20 | FDA warning letter | FDA warning letter: GenoGenix LLC (Compounding Pharmacy/Adulterated Drug Products) | FDA, GenoGenix LLC | Issued 01/20/2026, posted 03/03/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-01-16 | FDA warning letter | FDA warning letter: Boothwyn Pharmacy, LLC (Compounding Pharmacy/Adulterated Drug Products) | FDA, Boothwyn Pharmacy, LLC | Issued 01/16/2026, posted 02/10/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2026-01-14 | Lawsuit | Strive Compounding Pharmacy files antitrust suit against Eli Lilly and Novo Nordisk (W.D. Tex.) | Strive, Eli Lilly, Novo Nordisk | Alleges exclusive telehealth agreements barring platforms from working with compounders. | hmpgloballearningnetwork.com/site/pln/news/compounding-pharm... | secondary | day |
| 2026-01-05 | Label or price event | Wegovy pill (oral semaglutide) launches; NovoCare cash price $149-$299/month | Novo Nordisk, Wegovy, semaglutide | NovoCare savings page: $149/month for 1.5 mg and 4 mg (4 mg offer to Aug 31, 2026, then $199). Launch date per Noom price roundup (secondary). | novocare.com/patient/medicines/wegovy/savings-offer.html | secondary | approximate |
| 2025-12-12 | FDA warning letter | FDA warning letter to Pinnacle Professional Research dba Pinnacle Peptides (MARCS-CMS 719337) | FDA, Pinnacle Peptides | Unapproved new drugs sold as 'for research only / not for human use'; letter quotes SARMs (LGD-4033, MK-2866, S4 andarine) among products. | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-12-12 | FDA warning letter | FDA warning letter: MedisourceRx (Compounding Pharmacy/Adulterated Drug Products) | FDA, MedisourceRx | Issued 12/12/2025, posted 02/24/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-12-12 | FDA warning letter | FDA warning letter: Pinnacle Professional Research dba Pinnacle Peptides (Unapproved New Drugs) | FDA, Pinnacle Professional Research dba Pinnacle Peptides, peptide | Issued 12/12/2025, posted 12/23/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-12-03 | FTC action | FTC approves final order against NextMed | FTC, NextMed | Final order after comment period; prohibits deceptive advertising, billing and cancellation practices; $150,000. | ftc.gov/news-events/news/press-releases/2025/12/ftc-approves... | primary | day |
| 2025-12-01 | Label or price event | Eli Lilly cuts LillyDirect self-pay Zepbound vial prices to $299 (2.5 mg), $399 (5 mg), $449 (7.5-15 mg) | Eli Lilly, Zepbound, tirzepatide | Down from $349-$499; higher doses require refill within 45 days of prior delivery (Fierce Pharma). | cnbc.com/2025/12/01/eli-lilly-prices-zepbound-weight-loss-dr... | secondary | day |
| 2025-12-01 | FDA warning letter | FDA warning letter: Apothecary Pharma, LLC (Compounding Pharmacy/Adulterated Drug Products) | FDA, Apothecary Pharma, LLC | Issued 12/01/2025, posted 03/17/2026; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-11-17 | FDA warning letter | FDA warning letter: Handelnine Global, LLC dba Navafresh (Unapproved New Drugs/Adulterated/Misbranded) | FDA, Handelnine Global, LLC dba Navafresh | Issued 11/17/2025, posted 11/25/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-11-14 | Label or price event | Novo Nordisk cuts self-pay Wegovy/Ozempic to $349 and launches $199 two-month intro on lowest doses | Novo Nordisk, Wegovy, Ozempic, semaglutide | NovoCare Pharmacy terms: new self-pay patients pay $199/month for 0.25 mg and 0.5 mg for 2 monthly fills (offer since extended through Dec 31, 2026), then $349; Wegovy HD 7.2 mg $399. Reported mid-Nov 2025 by Fierce Pharma/CNBC. Date approximate to the announcement week. | novocare.com/pharmacy.html | primary | approximate |
| 2025-11-07 | FDA warning letter | FDA warning letter: Wells Pharma of Houston, LLC (Compounding Pharmacy/Adulterated Drug Products) | FDA, Wells Pharma of Houston, LLC | Issued 11/07/2025, posted 11/25/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-10-10 | FDA warning letter | FDA warning letter: PQ Pharmacy, LLC (Compounding Pharmacy/Adulterated Drug Products) | FDA, PQ Pharmacy, LLC | Issued 10/10/2025, posted 12/02/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-22 | FDA warning letter | FDA warning letter: Revive Rx LLC dba Revive Rx Pharmacy (Compounding Pharmacy/Adulterated Drug Products) | FDA, Revive Rx LLC dba Revive Rx Pharmacy | Issued 09/22/2025, posted 12/23/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-16 | FDA warning letter | FDA warning letter: Turbare Manufacturing (Compounding Pharmacy/Adulterated Drug Products) | FDA, Turbare Manufacturing | Issued 09/16/2025, posted 12/02/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-10 | FDA warning letter | FDA warning letter: motionpharmacy.com (Unapproved New Drug/Misbranded) | FDA, motionpharmacy.com | Issued 09/10/2025, posted 09/23/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA first wave: telehealth warning letters incl. Hims & Hers (Hers) and GLP-1 Solution for compounded semaglutide/tirzepatide/retatrutide claims | FDA, Hims & Hers, GLP-1 Solution, semaglutide, tirzepatide, retatrutide | Letters dated 09/09/2025 (posted 09/16/2025) cite false/misleading claims (e.g., 'same active ingredient as Ozempic and Wegovy') under FDCA 502(a)/502(bb); GLP-1 Solution letter also cites retatrutide as an unapproved new drug. 61 relevant letters carry Sept 2025 issue dates in the FDA database. | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Hims & Hers Health, Inc. dba Hers (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Hims & Hers Health, Inc. dba Hers, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: GenLabMeds (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, GenLabMeds, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: FitRX, LLC dba Zealthy (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, FitRX, LLC dba Zealthy, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: FWD Care, Inc. dba FWD (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, FWD Care, Inc. dba FWD, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: The HCG Institute (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, The HCG Institute, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Las Villas Health Care LLC dba Villas Health (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Las Villas Health Care LLC dba Villas Health, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Bioverse, Inc. dba Bioverse (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Bioverse, Inc. dba Bioverse, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Elevate Your Wellness LLC, dba Elevated (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Elevate Your Wellness LLC, dba Elevated, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Mane & Steel, LLC. dba Mane & Steel (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Mane & Steel, LLC. dba Mane & Steel, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Lumimeds (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Lumimeds, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: GLP-1 Solution (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, GLP-1 Solution, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Body Good Studio (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Body Good Studio, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Sprout Health Partners LLC dba Sprout Health (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Sprout Health Partners LLC dba Sprout Health, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Expert Aesthetics (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Expert Aesthetics, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Dermacare LLC dba BlueChew (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Dermacare LLC dba BlueChew, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Healthy Living Clinic (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Healthy Living Clinic, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Amazing Meds (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Amazing Meds, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Get.Fit.Medical, LLC dba Get.Fit.Medical (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Get.Fit.Medical, LLC dba Get.Fit.Medical, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: iVisitDoc, Inc. dba iVisitDoc (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, iVisitDoc, Inc. dba iVisitDoc, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Lean Dreams LLC dba LeanDreams (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Lean Dreams LLC dba LeanDreams, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: ybycmeds (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, ybycmeds, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Try Nova (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Try Nova, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Vitals RX (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Vitals RX, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Tuyo Health, Inc. dba Tuyo Health (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Tuyo Health, Inc. dba Tuyo Health, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Lovely Meds, Inc. dba Lovely Meds (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Lovely Meds, Inc. dba Lovely Meds, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Lyfe Rx (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Lyfe Rx, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: inspire.clinic (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, inspire.clinic, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: SimpleRx (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, SimpleRx, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Cosmo Medical Spa dba Cosmo Med Spa (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Cosmo Medical Spa dba Cosmo Med Spa, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: EvoLife Wellness (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, EvoLife Wellness, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: eDrugstore (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, eDrugstore, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Nuvo Life Health Inc. dba Nuvo Life Health (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Nuvo Life Health Inc. dba Nuvo Life Health, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: SemaBio (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, SemaBio, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: directmeds.com, Inc. dba DirectMeds (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, directmeds.com, Inc. dba DirectMeds, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Hims & Hers Health, Inc. dba Hims (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Hims & Hers Health, Inc. dba Hims, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: MedClub by Dr. Jenn (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, MedClub by Dr. Jenn, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: ASN-LABS (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, ASN-LABS, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Canada Med Stop (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Canada Med Stop, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: All American Wellness (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, All American Wellness, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Healthy Male (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Healthy Male, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Intimate Rose (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Intimate Rose, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Invigorate Med Spa (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Invigorate Med Spa, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Dr. Gater’s Weight Loss & Wellness (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Dr. Gater’s Weight Loss & Wellness, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Remedy Meds (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Remedy Meds, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: EA WORKS Limited Liability Company dba Trust Labs (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, EA WORKS Limited Liability Company dba Trust Labs, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Fancy Meds, LLC dba Fancy Meds (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Fancy Meds, LLC dba Fancy Meds, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Matthew Stern, CEO MyStart Health LLC. (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Matthew Stern, CEO MyStart Health LLC., telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Elite Health Center (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Elite Health Center, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Curex (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Curex, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Healthon Inc. dba Healthon (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Healthon Inc. dba Healthon, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: JulyMD (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, JulyMD, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Slendid (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Slendid, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Hello Cake, Inc. dba Hello Cake (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Hello Cake, Inc. dba Hello Cake, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Biopreventative Company LLC dba Biopreventative (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Biopreventative Company LLC dba Biopreventative, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Master Pharmaceuticals Group (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Master Pharmaceuticals Group, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: TRYM Health, Inc. dba TRYM Health (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, TRYM Health, Inc. dba TRYM Health, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: HealBerry (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, HealBerry, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-09-09 | FDA warning letter | FDA warning letter: Reset IV, LLC dba Reset IV (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)) | FDA, Reset IV, LLC dba Reset IV, telehealth | Issued 09/09/2025, posted 09/16/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-07-29 | FDA warning letter | FDA warning letter: cheaptrustedpharmacy.com (Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet) | FDA, cheaptrustedpharmacy.com | Issued 07/29/2025, posted 09/23/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-07-14 | FTC action | FTC announces action and proposed settlement against telehealth firm NextMed over deceptive GLP-1 weight-loss program marketing | FTC, NextMed, Southern Health Solutions | Complaint alleges undisclosed costs (drug, labs, consults not included in advertised price), one-year commitment, fake reviews/testimonials, unsubstantiated weight-loss claims, obstructed cancellations. $150,000 payment. | ftc.gov/news-events/news/press-releases/2025/07/ftc-takes-ac... | primary | day |
| 2025-07 | State board action | Ohio Board of Pharmacy GLP-1 guidance: semaglutide/tirzepatide not compoundable as copies post-shortage; retatrutide and cagrilintide prohibited; API must come from Ohio-licensed distributor | Ohio Board of Pharmacy, retatrutide, cagrilintide | Per Sheppard Mullin state survey (fetch returned HTTP 429; content from search index). Verify against Ohio BOP source before publishing. | sheppard.com/insights/blogs/above-the-federal-floor-how-stat... | secondary | approximate |
| 2025-06-12 | Court decision | Judge Pittman grants summary judgment to FDA in tirzepatide shortage case; dismissed with prejudice | OFA, FDA, Eli Lilly, tirzepatide | Sealed order upholding FDA's Dec 19, 2024 resolution determination (BioSpace/Lexology reports Jun 13, 2025). Followed a similar June 2025 ruling in the semaglutide case (The Hill, Jun 18, 2025). Exact order dates sealed; cite as mid-June 2025. | biospace.com/fda/lilly-wins-court-battle-against-compounders... | secondary | approximate |
| 2025-06-12 | FDA warning letter | FDA warning letter: www.buynetmeds.com (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet) | FDA, www.buynetmeds.com | Issued 06/12/2025, posted 07/01/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-05-05 | FDA warning letter | FDA warning letter: Staska Pharmaceuticals, Inc. (Compounding Pharmacy/Adulterated Drug Products) | FDA, Staska Pharmaceuticals, Inc. | Issued 05/05/2025, posted 07/01/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-05-05 | FDA warning letter | FDA warning letter: www.peacefulmeds.com (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet) | FDA, www.peacefulmeds.com | Issued 05/05/2025, posted 06/24/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-04-24 | Court decision | District court denies OFA preliminary injunction in semaglutide shortage case | OFA, FDA, semaglutide | FDA page entry dated [4/28/2025]: 'On April 24, 2025, the district court denied the plaintiffs' preliminary injunction motion in Outsourcing Facilities Association v. FDA, 4:25-cv-174'; compounding deadlines then ran (503A Apr 22 / 503B May 22, 2025). | fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-polic... | primary | day |
| 2025-04-23 | Lawsuit | Eli Lilly sues telehealth firms Mochi Health, Fella/Delilah Health, Willow Health, Henry Meds (N.D. Cal.) | Eli Lilly, Mochi Health, Fella Health, Willow Health, Henry Meds, tirzepatide | Complaints allege marketing of compounded tirzepatide, dose-switching to evade 'essentially a copy' rules, and oral tirzepatide never approved by FDA. | npr.org/sections/shots-health-news/2025/04/23/nx-s1-5374063/... | secondary | day |
| 2025-04-23 | FDA warning letter | FDA warning letter: OSRX, Inc. (Compounding Pharmacy/Adulterated Drug Products) | FDA, OSRX, Inc. | Issued 04/23/2025, posted 05/13/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-04-23 | FDA warning letter | FDA warning letter: www.24hreup.biz (Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet) | FDA, www.24hreup.biz | Issued 04/23/2025, posted 06/17/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-04-08 | FDA warning letter | FDA warning letter: Tailstorm Health Inc. dba Medivant Health (Compounding Pharmacy/Adulterated Drug Products) | FDA, Tailstorm Health Inc. dba Medivant Health | Issued 04/08/2025, posted 05/13/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-04-02 | FDA warning letter | FDA warning letter: Empower Clinic Services, LLC dba Empower Pharmacy (Compounding Pharmacy/Adulterated Drug Products) | FDA, Empower Clinic Services, LLC dba Empower Pharmacy | Issued 04/02/2025, posted 04/29/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-04-02 | FDA warning letter | FDA warning letter: Empower Clinic Services, LLC dba Empower Pharma (Compounding Pharmacy/Adulterated Drug Products) | FDA, Empower Clinic Services, LLC dba Empower Pharma | Issued 04/02/2025, posted 04/22/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-04-01 | Lawsuit | Eli Lilly sues Strive Pharmacy (D. Del.) and Empower Pharmacy (D.N.J.) over compounded tirzepatide marketing | Eli Lilly, Strive, Empower, tirzepatide | Lilly alleges false marketing of 'personalized' compounded tirzepatide; Strive case later dismissed for personal jurisdiction and refiled in Arizona (Oct 2025); Lilly refiled vs Empower in S.D. Tex. Jul 25, 2025 (Buchanan Ingersoll Aug 5, 2025 summary). | cnbc.com/2025/04/01/eli-lilly-sues-strive-and-empower-over-c... | secondary | day |
| 2025-03-05 | Court decision | Judge Pittman denies OFA preliminary injunction in tirzepatide shortage case (N.D. Tex. 4:24-cv-953) | OFA, FDA, Eli Lilly, tirzepatide | Sealed opinion and order denying motion for injunction entered 3/5/2025 (per Frier Levitt docket alert dated Mar 6, 2025). Secondary source; docket itself sealed. | frierlevitt.com/articles/alert-to-all-compounders-update-in-... | secondary | day |
| 2025-03-05 | FDA warning letter | FDA warning letter: Annovex Pharma, Inc. (Compounding Pharmacy/Adulterated Drug Products) | FDA, Annovex Pharma, Inc. | Issued 03/05/2025, posted 03/25/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-03-04 | FDA warning letter | FDA warning letter: ProRx, LLC (Compounding Pharmacy/Adulterated Drug Products) | FDA, ProRx, LLC | Issued 03/04/2025, posted 03/04/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-02-26 | FDA warning letter | FDA warning letter: USApeptide.com (Unapproved New Drugs/Misbranded) | FDA, USApeptide.com, peptide | Issued 02/26/2025, posted 03/11/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-02-24 | Court decision | OFA sues FDA over semaglutide shortage-list removal (N.D. Tex. 4:25-cv-174) | OFA, FDA, Novo Nordisk, semaglutide | Outsourcing Facilities Association filing listed 02/24/2025 on OFA advocacy page; case number confirmed in Fifth Circuit opinion No. 25-10758. | 503bs.org/advocacy | primary | day |
| 2025-02-21 | Drug shortage status | FDA declares semaglutide injection shortage resolved (Declaratory Order to Novo Nordisk) | FDA, Novo Nordisk, semaglutide, Ozempic, Wegovy | Declaratory Order dated Feb 21, 2025: Ozempic/Wegovy shortage resolved. Enforcement discretion for 503A compounders 60 days (to Apr 22, 2025) and 503B outsourcing facilities 90 days (to May 22, 2025). Same-day [2/21/2025] entry on FDA GLP-1 compounder page. | fda.gov/media/185526/download | primary | day |
| 2025-02-11 | Drug shortage status | FDA clarifies enforcement-discretion timeframes for compounded tirzepatide/semaglutide | FDA, tirzepatide, semaglutide | Dated [02/11/2025] entry on FDA's GLP-1 compounder policy page clarifying that enforcement-discretion periods were unchanged (503A tirzepatide to Feb 19, 2025; 503B to Mar 19, 2025). | fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-polic... | primary | day |
| 2025-01-22 | FDA warning letter | FDA warning letter: Nubratori, Inc. dba Nubratori Rx (Compounding Pharmacy/Adulterated Drug Products) | FDA, Nubratori, Inc. dba Nubratori Rx | Issued 01/22/2025, posted 04/15/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-01-13 | FDA warning letter | FDA warning letter: www.weightcrunchshop.com (Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet) | FDA, www.weightcrunchshop.com | Issued 01/13/2025, posted 01/21/2025; issuing office Center for Drug Evaluation and Research (CDER). Subject category from FDA warning-letter database (search terms: peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1, compounded). | fda.gov/inspections-compliance-enforcement-and-criminal-inve... | primary | day |
| 2025-01-07 | FDA policy or guidance | FDA finalizes revised Interim Policy on 503A/503B bulk substances (no new Category 1/2/3 placements for nominations on/after Jan 7, 2025) | FDA, 503A, 503B | Federal Register notice of availability of final guidance; FDA states it does not intend to place substances nominated on or after Jan 7, 2025 into the interim categories (confirmed on FDA 503A bulks page, current as of 05/14/2026). | federalregister.gov/documents/2025/01/07/2024-31546/interim-... | primary | day |
Methodology
- 1. One row per event. The date is the date on the primary document (letter issue date, opinion date, Federal Register publication date, or the 'content current as of' date on an FDA page). Where FDA posts a letter later than it was issued, both dates are kept in the summary.
- 2. Warning letters come from FDA's own database, searched weekly for peptide, semaglutide, tirzepatide, retatrutide, telehealth, GLP-1 and compounded. Every relevant 2025-2026 letter is included, not a sample.
- 3. Court, docket and agency events link to the opinion, order, notice or press release itself. Rows that rely on secondary reporting (law-firm summaries, news) are marked source_type = secondary with their date precision, and are replaced when the primary document is located.
- 4. A separate table records the compounding status of every peptide on the FormBlends calculator, with the FDA source and its date. Removal from Category 2 is not the same as being lawfully compoundable; that distinction is stated in each row.
- 5. Nothing here is legal advice. FormBlends sells compounded semaglutide and tirzepatide through licensed pharmacies and is affected by several of the actions listed; the tracker records them all the same.
Limits
- • The tracker records public actions. It does not evaluate the merits of any letter, lawsuit or rule, and it is not legal advice.
- • 12 rows rely on secondary reporting for a date or detail and are marked as such; they will be replaced when the primary document is available.
- • State board actions are captured by hand and may lag; their pages often carry no date stamp.
- • FormBlends is a telehealth seller of compounded GLP-1 drugs and is affected by several actions listed here.
Source ledger
regulatory · accessed 2026-09-04
U.S. Food and Drug Administration
FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss (content current as of 09/01/2026)
regulatory · accessed 2026-09-04
U.S. Food and Drug Administration
Warning Letters database
regulatory · accessed 2026-09-04
U.S. Food and Drug Administration
503A bulk drug substances category list (updated May 14, 2026)
regulatory · accessed 2026-09-04
U.S. Food and Drug Administration
Certain bulk drug substances for use in compounding that may present significant safety risks (content current as of 04/22/2026)
regulatory · accessed 2026-09-04
U.S. Food and Drug Administration
July 23-24, 2026 Pharmacy Compounding Advisory Committee meeting
primary · accessed 2026-09-04
U.S. Court of Appeals for the Fifth Circuit
Fifth Circuit opinion, No. 25-10600 (tirzepatide shortage case), affirmed August 27, 2026
primary · accessed 2026-09-04
U.S. Court of Appeals for the Fifth Circuit
Fifth Circuit opinion, No. 25-10758 (semaglutide shortage case), affirmed August 27, 2026
primary · accessed 2026-09-04
Federal Register
Federal Register docket FDA-2025-N-6895 (PCAC peptide nominations)
regulatory · accessed 2026-09-04
Federal Trade Commission
FTC action against Hims & Hers, July 29, 2026