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Empower Pharmacy

503A Outsourcing Facility — FDA safety data from public records

By FormBlends Editorial Team·

On This Page

FDA Registered503A Outsourcing Facility503B Facility

Large FDA-registered 503B outsourcing facility and compounder with a major national footprint in sterile and non-sterile medication production, including GLP-1-related products.

Website: empowerpharmacy.com

Data last verified: 2026-04-25

Company Snapshot

Entity Type

503A Outsourcing Facility

FDA Registration

active

Warning Letters

0

Recalls

1

States Licensed

Not listed

Compounding Status

503B

What This Company Profile Actually Tells You

Empower Pharmacy is categorized here as a 503B outsourcing facility or closely related sterile compounding operation. That matters because 503B facilities occupy a different regulatory lane than telehealth brands: they are physical drug establishments with FDA-facing registration obligations and manufacturing-style oversight expectations.

Empower Pharmacy's exact geographic footprint is not summarized on this page, so readers should confirm state availability before assuming access in their market. Readers evaluating a 503B facility should care about sterility controls, batch processes, inspection history, recalls, and whether the facility role being marketed to the public matches the legal operating status reflected in FDA records.

From a search and trust perspective, these pages need to answer a more technical question than a typical company review. Users are not just deciding whether they like the brand. They are trying to understand whether the facility is properly registered, how it is classified, and what public safety signals exist around its operations.

Empower Pharmacy Background

Market Position

Empower Pharmacy is one of the more prominent facilities in the compounding and outsourcing segment, and it appears often in discussions about who is actually supplying telehealth GLP-1 programs behind the scenes.

Business Model

Empower's role is fundamentally different from a telehealth brand. It operates as a production and fulfillment facility, which means readers should evaluate it through the lens of registration status, recall history, facility controls, and downstream pharmacy relationships rather than consumer-facing marketing polish.

Pharmacy And Supply Notes

When a telehealth company names Empower as a fulfillment partner, patients should read that as a facility-level sourcing clue, not as a complete safety answer. The more useful follow-up questions concern batch documentation, product pathway, and how issues are escalated if a shipment or potency concern arises.

Consumer Risk Notes

Empower's profile is stronger than a generic unknown supplier because the facility is visible in public records. At the same time, the recall shown on this page is exactly why users should not stop at 'FDA-registered' and assume the rest of the quality story is settled.

Key Facts

Empower is frequently relevant because it may be the actual compounding or outsourcing facility behind a telehealth prescription flow.

Its active FDA registration and scale make it easier to verify than an unnamed supplier, but registration alone is not a clean bill of health.

The recall and adverse-event summary on this profile give patients concrete reasons to ask more detailed quality and fulfillment questions.

Risk Summary

No FDA warning letters are currently shown in this profile.

1 recall event are listed in the FDA enforcement data surfaced here.

FDA registration status is shown as active.

Compounding status is listed as 503B.

12 adverse event reports are summarized, including 2 serious reports.

Regulatory And Compliance Analysis

Registration Context

Empower Pharmacy shows an active FDA registration record in the establishment database. That is a useful signal for facility verification, but it should still be read as registration data rather than a product approval or quality guarantee.

Warning Letter Readout

We did not find FDA warning letters for Empower Pharmacy in this profile. That is better than the alternative, but it is not a blanket endorsement. A clean warning-letter record only tells you that this page is not currently surfacing a published FDA warning letter tied to the entity.

Recall Readout

Empower Pharmacy has 1 recall event listed in this profile, including 1 classified as Class I or Class II. Recalls do not automatically mean a company is unsafe today, but they are highly relevant because they show a documented quality or distribution problem that reached the FDA enforcement system.

Adverse Event Context

Empower Pharmacy is associated here with 12 adverse event reports, of which 2 are marked serious. FAERS-style reporting can surface patterns worth attention, but these reports alone do not prove the company caused the event.

FDA Registration

Status
FDA Registered
FEI Number
3012837595
Facility Type
503B Outsourcing Facility
Last Verified
2026-04-10

Source: FDA Drug Establishment Registration & Listing

FDA Warning Letters (0)

No FDA warning letters are currently shown for Empower Pharmacy in this profile. That is helpful context, but users should still verify current marketing claims, pharmacy sourcing, and how the company describes compounded medications.

Recall History (1)

Class II2024-06-15Completed

Semaglutide Injection

Subpotency: some vials tested below labeled concentration

Source: openFDA Drug Enforcement API

Adverse Event Reports

12

Total Reports

2

Serious Reports

Q4 2025

Data Through

Most Reported Reactions

Nausea (4)Injection site reaction (3)Headache (2)

Source: FDA Adverse Event Reporting System (FAERS). Adverse event reports do not establish causation.

Questions Patients Should Ask Before Using Empower Pharmacy

Can Empower Pharmacy confirm the exact facility name, operating status, and whether the prescription will be filled under a 503A or 503B framework?

What does Empower Pharmacy tell patients about compounded versus FDA-approved products, and does that language avoid implying equivalence or approval where it does not exist?

How does Empower Pharmacy handle dose escalations, refill delays, refunds, cancellations, and temperature-sensitive shipping problems?

If a patient has a side effect or receives a product-quality concern, what is the human escalation path and how quickly does Empower Pharmacy respond?

Can Empower Pharmacy provide lot-level documentation, pharmacy details, and a clear explanation of what safety checks happen before medication is dispensed?

Similar Companies

These related profiles are useful for searchers comparing Empower Pharmacy against adjacent providers or pharmacies. Reading similar pages side by side usually reveals whether a concern is unique to one company or common across this category.

How To Use This Profile

This profile organizes public-source safety signals for Empower Pharmacy, including FDA registration status, warning letters, recalls, and any adverse event summary data available in the dataset.

A company can appear relatively clean here and still deserve more diligence, because absence of a warning letter or recall is not the same as proof of quality.

For 503a outsourcing facility pages especially, readers should distinguish between the consumer-facing brand and the pharmacy or facility that actually handles medication production or dispensing.

Primary Sources And Verification Links

Use these links to validate the key claims in this profile and to separate the consumer-facing brand story from the underlying regulatory record.

Empower Pharmacy official website

Primary facility website used to verify identity and national compounding-facility positioning.

Open source

Empower 503B facility page

Supports the 503B outsourcing-facility framing used throughout this profile.

Open source

openFDA drug enforcement recall database

Verification path for the recall information referenced on this page.

Open source

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Disclaimer: This page aggregates publicly available data from the FDA, state pharmacy boards, and other government sources. It is provided for informational purposes only and does not constitute medical or legal advice. FDA registration does not imply FDA approval or endorsement. The absence of warning letters or recalls does not guarantee safety or quality. Always consult your healthcare provider before making decisions about medications. Data may not reflect the most current status. Last updated: 2026-04-25.

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Frequently Asked Questions

Is Empower Pharmacy FDA registered?

Empower Pharmacy is currently registered with the FDA. Registration status was last verified on 2026-04-10. Note that FDA registration does not imply FDA approval or endorsement.

Has Empower Pharmacy received any FDA warning letters?

We have not found any FDA warning letters issued to Empower Pharmacy in our records. This page is updated regularly as new FDA data becomes available.

Does Empower Pharmacy have any recalls?

Yes, Empower Pharmacy has 1 recall in the FDA enforcement database. See the recall history section above for details.

Is Empower Pharmacy a telehealth company or a pharmacy?

Empower Pharmacy is categorized in this profile as a 503a outsourcing facility. That distinction matters because a telehealth brand, a 503A pharmacy, and a 503B outsourcing facility operate under different regulatory expectations.

Does a clean profile mean Empower Pharmacy is definitely safe?

No. A clean profile means we are not currently surfacing certain FDA signals like warning letters or recalls for Empower Pharmacy. It does not guarantee product quality, customer-service quality, or future regulatory compliance.

What should patients verify before using Empower Pharmacy?

Patients should verify who is prescribing, which pharmacy or outsourcing facility is actually fulfilling the medication, what the company says about compounded versus FDA-approved products, and how billing, cancellations, and side-effect escalation are handled.