FDA record · warning letter

FDA warning letter: PekCura Labs (Mar 31, 2026)

On Mar 31, 2026, FDA issued a warning letter to PekCura Labs of Pensacola, FL under the subject "Unapproved New Drugs Sold Over the Internet". It names glp-1 (named in the letter, no specific drug). 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 PekCura Labs
Field	What FDA’s record states	Source
Recipient	PekCura Labs	FDA letter
Location	Pensacola, FL	FDA letter
Letter date	Mar 31, 2026	FDA letter
Posted by FDA	Apr 7, 2026	FDA index
Issuing office	Center for Drug Evaluation and Research (CDER)	FDA letter
Subject	Unapproved New Drugs Sold Over the Internet	FDA letter
MARCS-CMS number	721709	FDA letter
GLP-1 drugs named	GLP-1 (named in the letter, no specific drug)	FDA letter
Response letter	Not published by FDA	FDA letter
Closeout letter	Not published by FDA	FDA letter

“The FDA has observed that your website offers “GLP-1-S” (all variations), “GLP-2-T” (all variations), “GLP-3-R” (all variations), and “Bacteriostatic Water” (all variations) (hereinafter PekCura Labs products) for sale in the United States. Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a).”FDA warning letter to PekCura Labs, Mar 31, 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.

Other GLP-1 letters FDA issued that week

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