FDA reports over 1,700 adverse events involving compounded GLP-1 drugs

The FDA has logged over 1,700 adverse event reports involving compounded semaglutide and tirzepatide. As of May 31, 2026, the agency recorded 990 reports for compounded semaglutide and over 730 for compounded tirzepatide. While the FDA notes these reports do not establish causation, it warns that totals may be undercounted because many state-licensed pharmacies are not required to report such events.

America’s Poison Centers reported 22,966 GLP-1 agonist exposure cases between 2019 and 2025, with a nearly 1,500% increase in calls during that period. While many cases involved accidental errors with FDA-approved drugs, compounded products have been linked to significant dosing mistakes, sometimes up to 10-fold, due to confusion over syringe measurement units.

In a related development, the FDA previously issued a warning letter to MEDVi, alleging the company obscured the actual source of its compounded products and misleadingly implied equivalence to FDA-approved drugs. Meanwhile, the clinical use of GLP-1 medications continues to expand beyond diabetes and weight management to include treating cardiovascular risk, diabetic kidney disease, and obstructive sleep apnea.