Q: What are the details of the Apothecary Pharma compounded tirzepatide weight-loss injection recall?

What was recalled, how to spot it, and why

A:Apothecary Pharma LLC voluntarily recalled 22 vials of compounded tirzepatide injection nationwide starting Sept. 24, 2026, and the FDA's stated reason was a lack of assurance of sterility. The FDA classified it Class II, meaning the product may cause temporary or medically reversible health problems, with the likelihood of serious harm considered low. A compounded drug is a pharmacy-prepared version of a medicine, so it has not undergone the same FDA review for safety, effectiveness, and quality.¹

ConsumerAffairs lists the recalled vials as Tirzepatide Injection, 18 mg/mL, 4 mL multidose, in lots AP-202622 through AP-202644 except AP-202626. Brand-name Mounjaro and Zepbound are unaffected, and patients with an affected vial should stop using it and contact their dispensing pharmacy and prescribing clinician for a replacement and/or appropriate next steps.² USA Today reported that distributor NewLife Rx told customers Apothecary called it a documentation issue, though neither the FDA nor Apothecary has publicly clarified the recall's reason.³

The recall follows a Dec. 1, 2025, FDA warning letter citing sterile-production deficiencies at Apothecary Pharma's facility, including inadequate glove sanitation and visibly rusty equipment.² ThePrint notes the warning letter does not, by itself, establish the recall's cause.¹ On our reading, a practice that sources compounded tirzepatide from outside compounders should check its inventory against the recalled lot numbers. For more about what the FDA has found with compounded injectables, see our compounded injectable risk.