FDA record · warning letter

FDA warning letter: Xcel Research LLC (Dec 10, 2024)

On Dec 10, 2024, FDA issued a warning letter to Xcel Research LLC of Sheridan, WY under the subject "Unapproved New Drugs/Misbranded". It names semaglutide, 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 Xcel Research LLC
Field	What FDA’s record states	Source
Recipient	Xcel Research LLC	FDA letter
Location	Sheridan, WY	FDA letter
Letter date	Dec 10, 2024	FDA letter
Posted by FDA	Dec 17, 2024	FDA index
Issuing office	Center for Drug Evaluation and Research (CDER)	FDA letter
Subject	Unapproved New Drugs/Misbranded	FDA letter
MARCS-CMS number	694608	FDA letter
GLP-1 drugs named	Semaglutide, Retatrutide	FDA letter
Response letter	Not published by FDA	FDA letter
Closeout letter	Not published by FDA	FDA letter

“This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address https://www.xcelpeptides.com in October 2024 and has observed that your website offers various products such as “RETA” (Retatrutide), “CagriLean” (Cagrilintide and Semaglutide), “CAGRILINTIDE,” “MAZDUTIDE,” “SEMA” (Semaglutide), “SURVODUTIDE,” and “SERMORELIN,” for sale in the United States.”FDA warning letter to Xcel Research LLC, Dec 10, 2024 · 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