Apothecary Pharma pulls tirzepatide injections over sterility concerns

Apothecary Pharma LLC, based in Cary, North Carolina, initiated a voluntary recall of 22 tirtirzepatide injection vials across the United States after the FDA could not verify sterility. The recalled product, tirzepatide 18 mg/mL in 4 mL multi-dose vials, includes lot numbers AP-202622 through AP-202644 with beyond-use dates ranging from Oct. 7 to Nov. 26, and also one 6 mL NAD+ injection vial (lot AP-202647). The FDA assigned a Class II recall status on Oct. 8, meaning the items could cause short-term or correctable health problems but are unlikely to cause serious injury.

This action follows a Dec. 2025 FDA warning letter that highlighted serious deficiencies in the company’s sterile-drug manufacturing practices. Neither the FDA nor Apothecary Pharma provided detailed disposal instructions, and the agency urges patients with the affected lots to discontinue use and contact their healthcare provider. The recall underscores ongoing regulatory scrutiny of compounded weight-loss medications, which the FDA has warned should be used only when approved alternatives are unavailable.