FDA warning letter cites Empower Pharmacy for insanitary conditions and pretextual compounding of tirzepatide and semaglutide
FDA's September 18 warning letter says Empower Pharmacy's Houston sterile operation had insanitary conditions and that its compounded tirzepatide and semaglutide appear to be copies of approved drugs.
The FDA has issued a warning letter to Empower Clinic Services, LLC, which does business as Empower Pharmacy, saying the company's Houston facility made sterile injectable drugs under insanitary conditions and compounded tirzepatide and semaglutide products that "appear to be essentially copies" of FDA-approved medicines [1]. The letter, numbered 738238 and addressed to founder and chief executive Arta Shaun Noorian, is dated September 18, 2026 [1].
FDA investigators inspected the site at 7601 N. Sam Houston Pkwy W. in Houston from November 3 through November 14, 2025, and issued a Form FDA 483 on the last day of the inspection [1]. The agency says it received written responses from the company dated December 8, 2025, March 18, 2026, and April 30, 2026 [1].
What the FDA found
On sterility, the letter says drug products intended to be sterile were "prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health" [1]. Specific observations included a failure to perform adequate smoke studies under dynamic conditions to show unidirectional airflow in the ISO 5 area, and media fill simulations that were not run under the most challenging conditions [1]. The agency also listed five current good manufacturing practice violations, including inadequate environmental monitoring in aseptic processing areas and a quality control unit that failed to ensure products met specifications for identity, strength, quality and purity [1].
The agency said some of Empower's corrective actions "appear adequate," but flagged others as incomplete or deficient [1]. A smoke study was executed March 30 through April 3, 2026, but remained "in controlled post-execution review" with no final report provided to the FDA [1]. A January 2026 media fill summary claimed no contamination in any vials, yet FDA's review of the underlying records found "gaps and discrepancies," including a vial count that did not match the summary report and entries marked "N/A" without explanation [1].
The second thread is legal. Under section 503A of the Federal Food, Drug, and Cosmetic Act, pharmacies may not regularly or in inordinate amounts compound copies of commercially available drugs, unless a prescriber documents a change that makes a significant difference for a specific patient [1]. FDA named three products: TIRZEPATIDE/NIACINAMIDE 4 mL (17/2 mg/mL), SEMAGLUTIDE/CYANOCOBALAMIN 1 mL (5/0.5 mg/mL), and TIRZEPATIDE/NIACINAMIDE 2.5 mL (8/2 mg/mL) [1]. Tirzepatide is sold by Eli Lilly as Mounjaro and Zepbound; semaglutide is sold by Novo Nordisk as Ozempic and Wegovy [2].
The letter lists monthly order volumes for July through October 2025, though the actual numbers are redacted in the public version [1]. FDA wrote that "the volume of products you are producing suggests that differences between products you are compounding and the FDA-approved products are pretextual" [1]. Some orders lacked any prescriber statement of significant difference; others carried statements that "appear to be repeated verbatim across many records," which the agency said suggests they were pre-generated for selection rather than written for an individual patient [1]. FDA singled out third-party technology platforms that offer prescribers pre-selected menu options, saying they call "the individualized nature of those determinations into question" [1].
Because the products do not qualify for the 503A exemptions, FDA classified them as adulterated, unapproved new drugs that are also misbranded for lacking adequate directions for use [1].
Why it matters for patients
Empower is a large supplier of compounded GLP-1 medications, and as of September 24 it continued to list tirzepatide and semaglutide products for sale on its website [2]. Compounded drugs are not FDA-approved, are not reviewed for safety, effectiveness or quality before marketing, and do not carry the agency's manufacturing oversight that applies to approved products [1].
It is important to be precise about what the letter does and does not say. FDA describes conditions under which products "may have become contaminated" [1]; it does not report confirmed contamination, patient injuries, or a recall. No recall or injury reports connected to this inspection have been reported. The sterility concerns apply regardless of whether Empower's products meet the conditions of section 503A [2].
The additive ingredients in the named products — niacinamide with tirzepatide and cyanocobalamin (vitamin B12) with semaglutide — are the kinds of formulation changes FDA said appear pretextual given the volumes involved [1].
What happens next
FDA gave Empower 15 working days from receipt of the September 18 letter to respond in writing with the specific steps it has taken to correct the violations and prevent them from recurring [2]. Empower's response to the warning letter has not been reported, and the agency has not announced further enforcement action.
Sources
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