FDA classifies Apothecary Pharma compounded tirzepatide recall as Class II
The North Carolina compounder pulled 22 lots of tirzepatide and one lot of NAD+ injection on September 24 over lack of sterility assurance.
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By Maren Holt · Senior Reporter, GLP-1
Oct 24 08:08 ETSource: Dallas News
The wire
- 01Apothecary Pharma LLC voluntarily recalled 22 vials of compounded tirzepatide, the active ingredient in Zepbound and Mounjaro, for lack of assurance of sterility; the FDA classified the action Class II on October 8.
- 02Gallup data cited in the report put US adult GLP-1 use near 11%, with roughly one in five of those users on compounded versions that do not undergo FDA premarket safety and quality review.
- 03Tirzepatide and semaglutide left the FDA shortage list in late 2024 and early 2025; patients should check lot numbers against the FDA notice, and no illnesses have been reported.
From the source
Read at dallasnews.comCompounded GLP-1 injections recalled over sterility concerns
Twenty-two vials of compounded GLP-1 medications were recalled over sterility concerns last month.
