FDA record · warning letter

FDA warning letter: Boothwyn Pharmacy, LLC (Jan 16, 2026)

On Jan 16, 2026, FDA issued a warning letter to Boothwyn Pharmacy, LLC of Kennett Square, PA under the subject "Compounding Pharmacy/Adulterated Drug Products". 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 Boothwyn Pharmacy, LLC
Field	What FDA’s record states	Source
Recipient	Boothwyn Pharmacy, LLC	FDA letter
Location	Kennett Square, PA	FDA letter
Letter date	Jan 16, 2026	FDA letter
Posted by FDA	Feb 10, 2026	FDA index
Issuing office	Center for Drug Evaluation and Research (CDER)	FDA letter
Subject	Compounding Pharmacy/Adulterated Drug Products	FDA letter
MARCS-CMS number	717525	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

“FDA also acknowledges that you ceased production of all GLP-1 drug products intended to be sterile and, on August 20, 2025, notified FDA of an intent to resume production of such products. Based on this inspection, it appears that you produced drug products that violate the Federal Food, Drug, and Cosmetic Act (FDCA).”FDA warning letter to Boothwyn Pharmacy, LLC, Jan 16, 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