FDA record · warning letter

FDA warning letter: Darmerica, LLC (Dec 8, 2025)

On Dec 8, 2025, FDA issued a warning letter to Darmerica, LLC of Davie, FL under the subject "CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded". It names retatrutide. 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 Darmerica, LLC
Field	What FDA’s record states	Source
Recipient	Darmerica, LLC	FDA letter
Location	Davie, FL	FDA letter
Letter date	Dec 8, 2025	FDA letter
Posted by FDA	Dec 23, 2025	FDA index
Issuing office	Center for Drug Evaluation and Research (CDER)	FDA letter
Subject	CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded	FDA letter
MARCS-CMS number	716152	FDA letter
GLP-1 drugs named	Retatrutide	FDA letter
Response letter	Not published by FDA	FDA letter
Closeout letter	Not published by FDA	FDA letter

“Distribution of drugs lacking adequate directions for use You received retatrutide from your supplier, (b)(4) , FEI (b)(4) . Retatrutide is a GLP-1 API that is not identified as an active ingredient in any drug approved by FDA.”FDA warning letter to Darmerica, LLC, Dec 8, 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