FDA classifies Apothecary Pharma tirzepatide recall as Class II over sterility
The voluntary recall began 24 September and covers 22 multidose vials of 18 mg/ml compounded tirzepatide plus one vial of compounded NAD+ injection.
MH
By Maren Holt · Senior Reporter, GLP-1
Oct 21 06:14 ETSource: ThePrint
The wire
- 01Outsourcing facility Apothecary Pharma recalled 22 vials of compounded tirzepatide 18 mg/ml, lots AP-202622 through AP-202644 with beyond-use dates of 7 October to 26 November, for lack of sterility assurance.
- 02Clinics and pharmacies sourcing compounded injectables should check lot numbers; the recall also covers one vial of the facility's compounded NAD+ injection.
- 03The FDA notice lists no reported injuries. Class II means temporary or reversible harm is possible with low likelihood of serious injury; a ProRx semaglutide recall of over 36,000 vials was similarly classified in 2025.
From the source
Read at theprint.inWhy 22 vials of compounded GLP-1 weight loss drugs have been recalled across the US
New Delhi: A compounding pharmacy, following a notice by the US FDA, has recalled 22 vials of compounded tirzepatide injections across the US over concerns that their sterility could not be assured. This has raised questions about the safety of injectable weight-loss drugs prepared by pharmacies rather than approved drug manufacturers.
