The U.S. Food and Drug Administration (FDA) has issued a nationwide recall for compounded GLP-1 tirzepatide injections manufactured by Apothecary Pharma. The recall, classified as Class II, addresses concerns over potential contamination in the widely used weight-loss medication.
Apothecary Pharma, a compounding pharmacy based in North Carolina, is recalling 22 vials of its compounded tirzepatide. Tirzepatide is the active ingredient in the brand-name drugs Mounjaro and Zepbound, but these specific brand-name medications are not affected by this recall. Patients who have received these compounded injections should check the vial's label for the manufacturer and lot number, as Apothecary Pharma supplies its compounded tirzepatide to several telehealth providers.
The recalled vials are labeled as 18 mg/mL in a 4 mL multi-dose vial. The affected lot numbers and their Beyond Use Dates (BUDs) include:
- AP-202622, BUD: 10/7/2026
- AP-202623, BUD: 10/8/2026
- AP-202624, BUD: 10/19/2026
- AP-202625, BUD: 10/20/2026
- AP-202627, BUD: 10/26/2026
- AP-202628, BUD: 10/27/2026
- AP-202629, BUD: 10/28/2026
- AP-202630, BUD: 10/31/2026
- AP-202631, BUD: 11/01/2026
- AP-202632, BUD: 11/03/2026
- AP-202633, BUD: 11/07/2026
- AP-202634, BUD: 11/08/2026
- AP-202635, BUD: 11/16/2026
- AP-202636, BUD: 11/17/2026
- AP-202637, BUD: 11/18/2026
- AP-202638, BUD: 11/19/2026
- AP-202639, BUD: 11/20/2026
- AP-202640, BUD: 11/21/2026
- AP-202641, BUD: 11/22/2026
- AP-202642, BUD: 11/24/2026
- AP-202643, BUD: 11/25/2026
- AP-202644, BUD: 11/26/2026
Apothecary Pharma is also recalling a NAD+ injection, a supplement often marketed for longevity, due to similar contamination concerns. Both recalls are designated Class II, indicating that the use of these products may cause temporary or medically reversible adverse health consequences, though severe health impacts are considered unlikely.
This recall follows previous regulatory action against Apothecary Pharma. In December, the FDA issued a warning letter to the company after an inspection revealed significant deficiencies in their sterile drug production practices, potentially putting patients at risk. These deficiencies included improper handling of sterile containers, inadequate gowning procedures, and the use of equipment that was difficult to clean and showed signs of rust.
Compounding pharmacies like Apothecary Pharma create alternative formulations of existing drugs, often to address medication shortages or meet specific patient needs. However, the FDA has raised concerns about the regulatory oversight of these compounded products. Unlike FDA-approved drugs, compounded medications are not subject to pre-market review for safety, effectiveness, or quality. The agency has previously flagged issues with compounded GLP-1s, including dosing errors, improper storage, and the use of fraudulent labeling.
The FDA has also expressed particular concern regarding multi-dose vials, such as those involved in this recall. These vials require patients to self-administer doses, increasing the risk of contamination over time, especially beyond 28 days. The FDA has received over 730 reports of adverse reactions linked to compounded tirzepatide, though the agency notes that such reports are likely undercounted.