GLP-1 injections recalled nationwide over sterility concerns

Apothecary Pharma is recalling 23 vials of injectable drugs distributed nationwide because their sterility cannot be assured, according to the Food and Drug Administration.

The voluntary recall includes 22 vials of compounded tirzepatide, a GLP-1 medication containing the same active ingredient as Eli Lilly's Mounjaro and Zepbound, and one vial of NAD+ injection. The FDA classified the recall as Class II on Oct. 8, indicating that serious health consequences are considered unlikely.

The recall follows a December 2025 FDA warning letter to Apothecary Pharma that cited serious deficiencies in the North Carolina company's sterile drug production practices. 

HOW GLP-1 WEIGHT-LOSS DRUGS ARE RESHAPING THE HEALTHCARE INDUSTRY

The agency said the problems put patients at risk, though it has not established a connection between those findings and the current recall.

The affected tirzepatide product is an 18 mg/mL prescription injection in a 4 mL multidose vial, with NDC number 85091-001-18. Recalled lots are AP-202622 through AP-202625 and AP-202627 through AP-202644, with beyond-use dates from Oct. 7 through Nov. 26, 2026.

The recalled NAD+ injection is a 200 mg/mL prescription product in a 6 mL multidose vial, NDC 85091-011-06. The affected lot is AP-202647, with a beyond-use date of Oct. 13, 2026.

Apothecary Pharma initiated the recall Sept. 24 and notified recipients by letter. The recall remains ongoing.

Consumers should check their vials or pharmacy records, stop using affected products and contact their pharmacist or prescriber for guidance. Anyone experiencing fever, redness, swelling or worsening pain after an affected injection should seek medical advice.

CLICK HERE TO GET FOX BUSINESS ON THE GO

The FDA notice did not identify any reported illnesses or injuries linked to the recall.