FDA record · warning letter

FDA warning letter: PQ Pharmacy, LLC (Oct 10, 2025)

On Oct 10, 2025, FDA issued a warning letter to PQ Pharmacy, LLC of Brooksville, FL under the subject "Compounding Pharmacy/Adulterated Drug Products". It names semaglutide. 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 PQ Pharmacy, LLC
Field	What FDA’s record states	Source
Recipient	PQ Pharmacy, LLC	FDA letter
Location	Brooksville, FL	FDA letter
Letter date	Oct 10, 2025	FDA letter
Posted by FDA	Dec 2, 2025	FDA index
Issuing office	Center for Drug Evaluation and Research (CDER)	FDA letter
Subject	Compounding Pharmacy/Adulterated Drug Products	FDA letter
MARCS-CMS number	715795	FDA letter
GLP-1 drugs named	Semaglutide	FDA letter
Response letter	Not published by FDA	FDA letter
Closeout letter	Not published by FDA	FDA letter

“Disposition was also not provided for the following products, including whether they were released or distributed: Product Lot number Production date Prednisolone Sodium Phosphate/Moxifloxacin HCl/Bromfenac PF PMB032025NFG 3/26/2025 Prednisolone Sodium Phosphate/Moxifloxacin HCl/Bromfenac PF PMB032025NFG1 (5.6mL) 3/28/2025 Prednisolone Sodium Phosphate/Moxifloxacin HCl/Bromfenac PF PMB032025EO1 (8.6mL) 3/28/2025 Semaglutide 5mg vials SEM032525JP 3/28/2025 3.”FDA warning letter to PQ Pharmacy, LLC, Oct 10, 2025 · 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