Apothecary Pharma's compounded tirzepatide injections recalled nationwide, FDA cites sterility lapse

The FDA has classified Apothecary Pharma LLC's voluntary nationwide recall of compounded tirzepatide injection vials, the active ingredient in Zepbound and Mounjaro, as a Class II recall due to a lack of assurance of sterility. The recall also covers one lot of the company's NAD+ injection. The FDA had sent Apothecary Pharma a warning letter in December 2025 citing serious deficiencies in its sterile drug manufacturing practices.

Why it matters. The recall adds to mounting FDA scrutiny of compounded GLP-1 products and could generate consumer injury and product-liability inquiries alongside other compounding-related litigation.