What to know about the GLP-1 injections recall
Key Points:
- Apothecary Pharma is recalling 22 vials of compounded tirzepatide and a NAD+ injection due to potential contamination, with the FDA classifying the recall as Class II, indicating possible temporary or reversible health effects.
- The recall affects compounded tirzepatide, the active ingredient in Mounjaro and Zepbound, but not the brand-name drugs themselves; however, patients should check their medication labels as compounded versions are supplied to several telehealth providers.
- The FDA previously issued a warning to Apothecary Pharma for serious sterility violations, including improper handling and unsanitary equipment, raising concerns about contamination risks in their drug production.
- Compounded GLP-1 drugs like tirzepatide are not FDA-reviewed for safety or effectiveness, and the agency has reported multiple adverse events, dosing errors, and storage issues related to these unregulated compounded medications.
- The FDA warns that multidose vials, such as those recalled, carry increased contamination risks, especially when patients self-administer doses over extended periods beyond recommended time frames.