FDA investigators inspected Empower’s 503A pharmacy in Houston from November 3 to 14, 2025. The resulting warning letter, addressed to founder and chief executive Arta Shaun Noorian, makes two separate sets of findings: that some of its GLP-1 products are unlawful copies, and that its sterile production fell short of federal manufacturing rules.[1]
The “add an ingredient” argument
Since the semaglutide and tirzepatide shortages ended, many compounders have sold versions mixed with B12 (cyanocobalamin) or niacinamide. The pitch is that the extra ingredient makes the product clinically different from Wegovy or Zepbound, so it is not a copy. The FDA did not accept that argument for the Empower orders it reviewed, naming tirzepatide/niacinamide and semaglutide/cyanocobalamin formulations that “appear to be essentially copies of FDA-approved semaglutide and tirzepatide products.”[1]
The agency pointed to the paperwork behind the orders. It cited “orders/prescriptions that lack any prescriber determination of significant difference,” and said some of the determinations that did exist “appear to be repeated verbatim across many records,” suggesting “they may be pre-generated for selection by the prescriber.” It added that “the volume of products you are producing suggests that differences” between Empower’s products and “the FDA-approved products are pretextual.”[1]
A footnote restates the timeline: the FDA’s period of enforcement discretion for state-licensed pharmacies “ended with respect to tirzepatide injection products on March 5, 2025.”[1]
The sterile-production findings
The letter separately lists insanitary conditions and manufacturing (CGMP) violations, including that the firm:[1]
- “failed to perform adequate smoke studies under dynamic conditions” to show clean, one-way airflow in its ISO 5 sterile area;
- ran media fills, the tests that simulate sterile filling, that “were not performed under the most challenging or stressful conditions”;
- “failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas”; and
- had a quality control unit that “failed to exercise its responsibility.”
Empower had 15 working days to reply in writing with the steps it had taken. The FDA warned that failing to fix the violations “may result in legal action without further notice.”[1] A warning letter is not a recall or a shutdown order, and it does not say any patient was harmed.
What it means if you use a compounded GLP-1
If your telehealth plan ships a semaglutide or tirzepatide “with B12,” ask which pharmacy fills it and what clinical reason your prescriber recorded for the added ingredient. Our explainers on why semaglutide is compounded with B12 and why tirzepatide is compounded with B12 cover what the evidence says about the additive itself, and compounded tirzepatide’s current FDA status covers the rules. The full letter is summarized in our FDA warning letter tracker.