FDA updates its warning page on unapproved GLP-1 drugs

| Safety and regulation

The FDA refreshed its page on unapproved GLP-1 drugs used for weight loss. It says compounded semaglutide and tirzepatide are not FDA-approved and are not reviewed for safety, effectiveness or quality before sale. As of May 31, 2026 it had 990 adverse event reports for compounded semaglutide and more than 730 for compounded tirzepatide, which it says are likely underreported.

Worth knowing: The page also covers dosing errors, counterfeit products and products sold "for research" but marketed for human use. The Atlas explains the differences on its compounded versus brand-name page.

Related: Compounded versus brand-name medicines | Compounded GLP-1s: what FDA safety reports show

Source: U.S. Food and Drug Administration. Page content current as of October 1, 2026. Adverse event counts are as of May 31, 2026 Regulator.

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