Apothecary Pharma Recalls Tirzepatide Injections Due to Sterility Concerns

Apothecary Pharma LLC has initiated a nationwide Class II recall of 22 vials of its compounded tirzepatide injection (18 mg/mL, 4 mL multi-dose vials) due to a lack of assurance of sterility. The recall, which began on September 24, 2026, was classified as Class II by the FDA on October 8, 2026, meaning exposure to the affected medication could cause temporary or medically reversible adverse health consequences, though serious harm is unlikely. The FDA had previously issued a warning letter to Apothecary Pharma in December 2025, citing serious deficiencies in their practices for producing sterile drug products.