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Apothecary Pharma is recalling 23 vials of injectable medications distributed nationwide because their sterility cannot be guaranteed, according to the Food and Drug Administration.
The voluntary recall includes 22 vials of compound tirzepatide, a GLP-1 drug 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 October 8, indicating that serious health consequences are considered unlikely.
The recall follows a December 2025 FDA warning letter to Apothecary Pharma citing serious deficiencies in the North Carolina company’s sterile drug production practices.
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The voluntary recall includes 22 vials of compound tirzepatide, a GLP-1 drug containing the same active ingredient as Eli Lilly’s Mounjaro and Zepbound, and one vial of NAD+ injection. (iStock)
The agency said these problems put patients at risk, although it did not link these findings to the current recall.
The affected tirzepatide product is a 18 mg/mL prescription injection in a 4 mL multidose vial, NDC number 85091-001-18. The recalled lots are AP-202622 to AP-202625 and AP-202627 to AP-202644, with best-before dates of October 7 to November 26, 2026.
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The recalled NAD+ Injection is a 200 mg/mL prescription product in a 6 mL multidose vial, NDC 85091-011-06. The affected batch is AP-202647, with a best-before date of October 13, 2026.
Apothecary Pharma initiated the recall on September 24 and notified recipients by letter. The recall remains in progress.
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Consumers should check their bottles or pharmaceutical records, stop using the affected products and contact their pharmacist or prescriber for advice. Anyone experiencing fever, redness, swelling, or worsening pain after an affected injection should seek medical attention.
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The FDA advisory did not identify any reported illnesses or injuries related to the recall.
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