FDA record · warning letter

FDA warning letter: GenLabMeds (Sep 9, 2025)

On Sep 9, 2025, FDA issued a warning letter to GenLabMeds under the subject "Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)". It names semaglutide, tirzepatide, 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 GenLabMeds
Field	What FDA’s record states	Source
Recipient	GenLabMeds	FDA letter
Location	Not published by FDA	n/a
Letter date	Sep 9, 2025	FDA letter
Posted by FDA	Sep 16, 2025	FDA index
Issuing office	Center for Drug Evaluation and Research (CDER)	FDA letter
Subject	Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)	FDA letter
MARCS-CMS number	713650	FDA letter
GLP-1 drugs named	Semaglutide, Tirzepatide, Retatrutide	FDA letter
Response letter	Not published by FDA	FDA letter
Closeout letter	Not published by FDA	FDA letter

“As described below, your retatrutide drug products are unapproved new drugs and misbranded drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a), 502(f)(1), 301(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 355(a), 352(f)(1), 331(a) and 331(d)].”FDA warning letter to GenLabMeds, Sep 9, 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.

Other GLP-1 letters FDA issued that week

And 48 more in the full list.

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