FDA record · warning letter

FDA warning letter: Empower Clinic Services, LLC dba Empower Pharmacy (Sep 18, 2026)

On Sep 18, 2026, FDA issued a warning letter to Empower Clinic Services, LLC dba Empower Pharmacy of Houston, TX under the subject "CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug". It names semaglutide, tirzepatide. Open: no closeout letter published as of Oct 3, 2026.

Julian CaraulaniFounder, PriceTracker GLP-1FDA record read Oct 3

Status: Open: no closeout letter published as of Oct 3, 2026.

What FDA’s record states

FDA record for the warning letter to Empower Clinic Services, LLC dba Empower Pharmacy
Field	What FDA’s record states	Source
Recipient	Empower Clinic Services, LLC dba Empower Pharmacy	FDA letter
Location	Houston, TX	FDA letter
Letter date	Sep 18, 2026	FDA letter
Posted by FDA	Sep 22, 2026	FDA index
Issuing office	Center for Drug Evaluation and Research (CDER)	FDA letter
Subject	CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug	FDA letter
MARCS-CMS number	738238	FDA letter
GLP-1 drugs named	Semaglutide, Tirzepatide	FDA letter
Response letter	Not published by FDA	FDA letter
Closeout letter	Not published by FDA	FDA letter

“Specifically, your firm compounded products including 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), which appear to be essentially copies of FDA-approved semaglutide and tirzepatide products.”FDA warning letter to Empower Clinic Services, LLC dba Empower Pharmacy, Sep 18, 2026 · read the full letter on fda.gov ↗

What this is and is not.A warning letter is FDA’s statement of what it considers significant violations. It is an allegation, not a court finding, and the firm can respond. A closeout letter is posted when FDA confirms the violations were corrected.

Source

Every field above is copied from FDA’s page for this letter, read Oct 3, 2026. The letter on fda.gov ↗ · All 161 GLP-1 warning letters