FDA Building 1, the main entrance that houses the Commissioner's and Senior Staff's offices, on the agency's White Oak campus
The U.S. Food and Drug Administration
Illustrative. FDA's own headquarters building, not the Empower Pharmacy facility the warning letter concerns.
The FDA Just Hit Its Biggest Compounded GLP1 Pharmacy With a Third Warning Letter
I've written before about how tempting the compounded route looks next to a brand name Ozempic or Zepbound pen, cheaper, easier to get, often delivered straight to your door. This week the FDA put a real number on what some of that savings might be quietly costing. Empower Pharmacy, one of the biggest names in compounded GLP1 products, just picked up its third warning letter in nine years, and this one names actual sterility failures in the rooms making injectable drugs.
- The FDA sent Empower Pharmacy, one of the largest sellers of compounded semaglutide and tirzepatide, its third warning letter in nine years, dated September 18, 2026.
- The letter says Empower's tirzepatide plus niacinamide and semaglutide plus cyanocobalamin products are essentially copies of two FDA approved drugs, which compounding pharmacies are not allowed to make in volume.
- FDA inspectors also found real sterility gaps, including inadequate smoke studies, inconsistent media fill records, and missing contamination control procedures for the injectable products Empower makes.
- This is not a recall. Empower has 15 business days to respond, and it is also a named defendant in Eli Lilly's lawsuit over compounded tirzepatide.
What the FDA actually found
On September 18, 2026, the FDA sent Warning Letter number 738238 to Empower Clinic Services LLC, doing business as Empower Pharmacy, a large 503A and 503B compounding pharmacy that has become one of the biggest suppliers of compounded tirzepatide and semaglutide since brand name shortages made those drugs hard to get. Inspectors visited Empower's facility between November 3 and November 14 of 2025, and what they found lands on two separate problems, not one.
The first is a legal one. Federal law lets compounding pharmacies operate under Section 503A specifically because they are not supposed to be regularly making copies of a drug a manufacturer already sells. The letter states that the volume of Empower's tirzepatide plus niacinamide and semaglutide plus cyanocobalamin, a form of vitamin B12, products "suggests that differences between products you are compounding and the FDA approved products are pretextual." In plain language, the FDA is saying the added ingredients look like a legal workaround rather than a genuine reason a specific patient needed something the approved drug does not offer.
The second problem is sterility, and it is the part that actually matters to anyone who has ever injected one of these products. Inspectors found inadequate dynamic smoke studies, which are supposed to verify that air actually flows the way a sterile production room needs it to, incomplete and inconsistent media fill documentation, and missing written procedures for preventing microbial contamination in the areas making injectable drugs.
This is the third time, not the first
Empower has now received FDA warning letters in 2017, in April 2025, and again this September. It also sits as a named defendant in a lawsuit Eli Lilly filed over compounded tirzepatide. None of that means every dose Empower has ever sold was contaminated. It does mean the company keeps showing up in the FDA's own enforcement record, at a company a lot of people are trusting with an injectable drug.
- 2017
- Empower's first FDA warning letter.
- April 2025
- A second warning letter, letter number 700964.
- September 2026
- This letter, number 738238, citing volume that suggests the compounded products are pretextual copies of approved drugs, plus sterility gaps in the rooms making injectable products.
Honest caveat
A warning letter is not a recall, and it is not proof that a specific dose sold to a specific patient was actually contaminated. It documents what FDA investigators found during one inspection window in November 2025 and gives Empower 15 business days to respond with corrective action. This brief does not have Empower's response to the September letter yet. Coverage from Fierce Pharma, Endpoints News, and SafeMedicines.org all treats the letter as authoritative, which makes sense since it is a primary government document, not a contested claim, but the company's own side of the sterility findings specifically has not been reported yet.
What this means for you
If you are one of the many people who have gone the compounded route for semaglutide or tirzepatide because the brand name pens are expensive or hard to get, this letter is about as concrete a data point as you are going to find on whether that tradeoff is actually safe. It does not prove your specific vial was contaminated. It does mean one of the largest suppliers in that market has now failed an FDA sterility inspection for the third time in nine years, on a drug you inject. That is worth knowing before your next refill, whichever pharmacy you use.
Primary sources
- FDA Warning Letter, Empower Clinic Services LLC dba Empower Pharmacy, 738238, September 18, 2026
- FDA Warning Letter, Empower Clinic Services LLC dba Empower Pharmacy, 700964, April 2, 2025 (prior letter)
- Fierce Pharma: "Texas outsourcer in Lilly's compounded tirzepatide lawsuit hit with FDA warning letter"
Common questions
Is compounded semaglutide or tirzepatide now illegal?
No. A warning letter is a regulatory finding about one company's manufacturing practices and legal compliance, not a ban on compounded GLP1 drugs generally. Compounding remains legal under specific conditions, and this letter says Empower specifically crossed the line those conditions draw.
What happens next for Empower?
The FDA gave Empower 15 business days from September 18, 2026, to respond with corrective actions, putting a response due around early to mid October 2026. Empower is also a named defendant in Eli Lilly's ongoing lawsuit over compounded tirzepatide, a separate legal track from this warning letter.
How can I tell if my compounding pharmacy has had FDA problems?
FDA warning letters are public and searchable on FDA.gov's own warning letters database by company name. It is a reasonable five minute check before choosing or renewing with any compounding pharmacy, not only for GLP1 drugs.
Stay Curious.
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