FDA record · warning letter

FDA warning letter: Curex (Sep 9, 2025)

On Sep 9, 2025, FDA issued a warning letter to Curex of Miami, FL under the subject "Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)". 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 Curex
Field	What FDA’s record states	Source
Recipient	Curex	FDA letter
Location	Miami, FL	FDA letter
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	716821	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

“As described below, your claims concerning compounded semaglutide and tirzepatide products are false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 352(a) and 352(bb)], resulting in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)].”FDA warning letter to Curex, 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