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> Reviewed by FormBlends Medical Team · Last updated May 2026 · 10 sources cited
Key Takeaways
- Tirzepatide was removed from the FDA Drug Shortages Database on October 2, 2024, ending a multi-year shortage that affected both Mounjaro and Zepbound.
- The resolution preceded the semaglutide shortage resolution (February 21, 2025) by several months because Eli Lilly's manufacturing expansion outpaced Novo Nordisk's.
- Higher dose strengths (10 mg, 12.5 mg, 15 mg) had been the most constrained during the shortage; resolution required all dose strengths to be sustainably available.
- The end of the shortage substantially narrowed the FDA-recognized basis for compounding tirzepatide under section 503A.
- Pharmacy-level availability can still fluctuate, but no national shortage is in effect as of May 2026.
Direct answer
No national Zepbound shortage is listed by the FDA as of May 2026. The FDA Drug Shortages Database removed tirzepatide injection on October 2, 2024, after Eli Lilly demonstrated sustained production across all dose strengths. Both Zepbound (weight management) and Mounjaro (diabetes) share the tirzepatide shortage classification and both are listed as available.
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Start Free Assessment →Table of contents
- The current FDA status
- The tirzepatide shortage timeline
- Why Zepbound's launch created supply pressure
- Why tirzepatide recovered before semaglutide
- What the resolution means for compounded tirzepatide
- Eli Lilly's manufacturing footprint
- Why dose-strength matters in shortage analysis
- What could cause another shortage
- What patients should actually do
- FAQ
- Sources
The current FDA status
The FDA Drug Shortages Database is the authoritative public source. As of May 2026, tirzepatide injection is not listed. The database shows the resolution date as October 2, 2024, with all Zepbound dose strengths (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg) and corresponding Mounjaro dose strengths marked available.
Zepbound and Mounjaro share the same active ingredient (tirzepatide), the same FDA shortage classification, and resolve together when the classification changes.
The tirzepatide shortage timeline
| Date | Event |
|---|---|
| May 2022 | FDA approves Mounjaro for type 2 diabetes. |
| Late 2022 to 2023 | Mounjaro demand exceeds initial fill-finish capacity; tirzepatide added to the FDA shortage list. |
| 2023 | Eli Lilly announces multiple capacity expansions, including the Concord, North Carolina facility. |
| November 8, 2023 | FDA approves Zepbound for chronic weight management; demand intensifies on the same supply. |
| 2024 (first half) | Higher dose strengths remain constrained; lower starter doses available periodically. |
| October 2, 2024 | FDA removes tirzepatide from the shortage list. |
| December 2024 to early 2025 | Compounding wind-down period for tirzepatide. |
| May 2026 | Supply stable; no national shortage. |
Why Zepbound's launch created supply pressure
Tirzepatide's clinical profile and launch timing produced unusual demand growth.
The pivotal SURMOUNT-1 trial (Jastreboff et al., New England Journal of Medicine, 2022) reported mean weight loss of approximately 22.5 percent at the 15 mg dose over 72 weeks, the largest figure in published GLP-1 weight-loss trials at the time. That efficacy data drove both clinician interest and patient demand.
When Zepbound received FDA approval in November 2023, the launch occurred while:
- Mounjaro was already on the FDA shortage list for diabetes use.
- Off-label tirzepatide prescribing for weight loss had been growing.
- Semaglutide was simultaneously in shortage, channeling some demand toward tirzepatide.
Eli Lilly's existing fill-finish capacity, optimized for the slower ramp of Mounjaro alone, could not absorb the combined Mounjaro plus Zepbound demand in the short term.
Why tirzepatide recovered before semaglutide
The tirzepatide shortage resolved (October 2024) about four months before the semaglutide shortage (February 2025). Several reasons explain the earlier resolution.
Reason 1: Eli Lilly's capacity investment timing. The company committed to large fill-finish expansions, including the Concord, North Carolina site that came online during 2023 and 2024. The capacity reached production volumes faster than some industry observers expected.
Reason 2: A later launch window for the obesity indication. Zepbound launched in November 2023, well after Mounjaro and only modestly before the resolution. The total demand load on tirzepatide compounded over a shorter period than the semaglutide load.
Reason 3: Different market positioning. Some payers and prescribers held back on tirzepatide adoption during 2023 pending experience with the new molecule, moderating early demand growth.
Reason 4: Coordination on compounding. Eli Lilly aggressively pursued litigation against compounding pharmacies during the shortage, which constrained the compounded tirzepatide market more tightly than the compounded semaglutide market.
What the resolution means for compounded tirzepatide
FDCA section 503A allows state-licensed compounding pharmacies to compound drugs that are on the FDA shortage list, in response to individual prescriptions. When tirzepatide was removed from the shortage list on October 2, 2024, that legal basis narrowed substantially.
Key transitions:
- The FDA announced a transition timeline for 503A compounding to wind down.
- Eli Lilly intensified litigation against compounding pharmacies, telehealth platforms, and medical spas alleged to be marketing compounded tirzepatide as equivalent to Zepbound or Mounjaro.
- Patients on compounded tirzepatide either transitioned to brand-name Zepbound or Mounjaro, switched to semaglutide products, or discontinued therapy.
- By May 2026, the broad compounded tirzepatide market that existed during the shortage no longer operates at scale.
Narrow patient-specific compounding remains possible for documented clinical needs that brand-name products cannot meet (such as a true allergy to an excipient), but the volume is dramatically smaller than during the shortage period.
Eli Lilly's manufacturing footprint
Eli Lilly's tirzepatide production occurs across several sites.
| Site | Country | Role |
|---|---|---|
| Indianapolis area | United States | Headquarters; legacy manufacturing |
| Concord, North Carolina | United States | Major injectable manufacturing investment, opened 2023 |
| Lebanon, Indiana | United States | Future API capacity; in build-out |
| Limerick | Ireland | API and fill-finish |
| Kinsale | Ireland | Active pharmaceutical ingredient |
| Branchburg, New Jersey | United States | Fill-finish (added via acquisition) |
Eli Lilly's distributed footprint mirrors Novo Nordisk's strategy: US manufacturing close to the largest market, Irish API capacity, and acquisitions or partnerships to add capacity faster than greenfield builds would allow.
Why dose-strength matters in shortage analysis
FDA shortage classification depends on all dose strengths being sustainably available, not just the starter doses. During the tirzepatide shortage, lower doses (2.5 mg, 5 mg) often returned to availability earlier than higher doses (10 mg, 12.5 mg, 15 mg).
Higher doses are typically the long-term maintenance doses for patients titrated up. A patient who titrates from 2.5 mg to 5 mg over the first eight weeks needs higher doses by month three onward. Constraint at the high doses can leave existing patients without the medication strength they need even when starter doses are available.
Resolution requires that the manufacturer produce all dose strengths at volumes sufficient to support both new patient starts and ongoing maintenance. Eli Lilly reached that level by October 2024 across the Mounjaro and Zepbound dose ranges.
What could cause another shortage
The plausible triggers for a future tirzepatide shortage include:
- SURMOUNT-MMO and other cardiovascular outcomes data. If forthcoming trials show large cardiovascular benefit, payer coverage could expand quickly, pulling new patient populations into the market.
- Approvals for additional indications. Investigated uses including obstructive sleep apnea, MASH (formerly NASH), and other conditions could broaden the eligible population.
- A manufacturing disruption. Any incident at a major Eli Lilly site could constrain production.
- FDA inspection findings. A 483 or warning letter affecting a critical site could pause production temporarily.
- Demand from new geographies. If Eli Lilly's international expansion accelerates, US-bound supply could be re-balanced.
None of these are predicted, but each is plausible enough to deserve monitoring.
What patients should actually do
- If you have been waiting for Zepbound or Mounjaro supply, the wait is no longer driven by national shortage. Confirm with your pharmacy.
- If you have been on compounded tirzepatide, discuss transition options with your clinician. The compounding basis has narrowed considerably.
- If you are considering starting tirzepatide, supply availability is not a barrier; payer coverage and cost are.
- If your pharmacy is out of a specific dose, check with another local pharmacy or your insurance-affiliated network before assuming a shortage.
- Use the FDA Drug Shortages Database or your pharmacy for live information rather than news headlines.
The contrary view: why GLP-1 supply remains structurally fragile
For balance, calling the shortage resolved should not mean dismissing structural concerns.
- Two-company concentration. Novo Nordisk and Eli Lilly produce the entire FDA-approved GLP-1 supply. Any major disruption to either company affects the whole class.
- Long capacity lead times. Adding fill-finish capacity takes years. Demand can grow faster than supply within a single cycle.
- Coverage volatility. Sudden payer policy changes can shift demand by millions of patients in a quarter, faster than supply can respond.
- Compounding has been disrupted. The compounded supply that absorbed unmet demand during the shortage is no longer available at the same scale.
The supply system is healthier than it was in 2023, but it is not robust to large positive demand shocks. Future shortage risk is real even if the current snapshot is favorable.
FAQ
Is there a Zepbound shortage in 2026?
No. Tirzepatide was removed from the FDA shortage list on October 2, 2024, and the resolution remains in effect.
Is Mounjaro in shortage?
No. Mounjaro shares the tirzepatide shortage classification with Zepbound and was resolved at the same time.
Why did Zepbound recover before Ozempic?
Eli Lilly's capacity expansion came online earlier than Novo Nordisk's, and the cumulative demand load on tirzepatide was somewhat lower than on semaglutide because Zepbound launched in November 2023, later than Wegovy.
Where is Zepbound made?
Eli Lilly manufactures tirzepatide at facilities in Indiana, North Carolina, New Jersey, and Ireland, among others.
Can I still get compounded tirzepatide?
Broad shortage-tolerance compounding ended after October 2024. Narrow patient-specific compounding remains possible only in limited circumstances.
What if my pharmacy is out of my dose?
Check with another pharmacy or your insurer's preferred pharmacy network. Pharmacy-level stock-outs are not the same as a national shortage.
Is there a generic Zepbound?
No. Tirzepatide is patent-protected. No FDA-approved generic exists.
How do I check supply status myself?
The FDA Drug Shortages Database is the official source. Your pharmacy can verify specific NDC availability.
Related guides
- Is There an Ozempic Shortage in 2026? The Current Supply Picture
- Where Is Ozempic Manufactured? Mapping Novo Nordisk's Global Supply Chain
- The GLP-1 Supply Chain Explained: How the Shortage Happened, What Fixed It, What Compounding Did
- Does Zepbound Cause Blindness? Eye Safety for the Weight-Management Tirzepatide
- Does Zepbound Cause Cancer? Reading the Boxed Warning Against the Tirzepatide Evidence Base
- Drinking on Zepbound: How Tirzepatide Changes Alcohol Tolerance, Craving, and Risk
Sources
- US Food and Drug Administration. Drug Shortages Database. Tirzepatide injection resolution, October 2, 2024.
- US Food and Drug Administration. Drug Shortages Database. Semaglutide injection resolution, February 21, 2025.
- US Food and Drug Administration. Zepbound Prescribing Information.
- US Food and Drug Administration. Mounjaro Prescribing Information.
- Jastreboff AM, Aronne LJ, Ahmad NN, et al. Tirzepatide Once Weekly for the Treatment of Obesity (SURMOUNT-1). New England Journal of Medicine. 2022.
- Aronne LJ, Sattar N, Horn DB, et al. Continued Treatment With Tirzepatide for Maintenance of Weight Reduction (SURMOUNT-4). JAMA. 2024.
- Eli Lilly and Company. 2024 Annual Report on Form 10-K. Manufacturing and capacity disclosures.
- Federal Food, Drug, and Cosmetic Act. Section 503A.
- FDA. Guidance for Industry: Compounding Animal and Human Drugs Under Section 503A. Current edition.
- American Society of Health-System Pharmacists. Drug Shortages Resource Center.
Footer disclaimers
Platform Disclaimer. FormBlends provides general information about FDA shortage status. Patients should verify live status through the FDA Drug Shortages Database. This article does not replace clinical guidance.
Compounded Medication Notice. Compounded tirzepatide is not FDA-approved. After the October 2024 shortage resolution, the legal basis for compounding tirzepatide under FDCA section 503A narrowed substantially. Patient-specific compounding remains possible only in narrow circumstances.
Results Disclaimer. Trial averages cited (e.g., SURMOUNT-1) describe group-level outcomes that may not match any individual patient's response. Treatment outcomes vary.
Trademark Notice. Zepbound and Mounjaro are registered trademarks of Eli Lilly and Company. Ozempic and Wegovy are registered trademarks of Novo Nordisk A/S. FormBlends is not affiliated with either manufacturer.
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