The Food and Drug Administration (FDA) classified Apothecary Pharma, LLC’s U.S. recall of 22 compounded tirzepatide lots and one lot of Apothecary NAD+ Injection as Class II, citing “Lack of Assurance of Sterility.” The company began the voluntary recall Sept. 24, 2026; the FDA assigned the classification Oct. 8.
The tirzepatide product is an 18 mg/mL injection supplied in 4 mL multidose vials under National Drug Code 85091-001-18. The FDA list includes AP-202622 through AP-202625 and AP-202627 through AP-202644; their beyond-use dates run from Oct. 7 to Nov. 26, 2026. The 22 figure counts lots, not individual vials.
The separate Apothecary NAD+ Injection listing identifies a 200 mg/mL product in a 6 mL multidose vial, National Drug Code 85091-011-06. It covers lot AP-202647, which has an Oct. 13, 2026, beyond-use date.
An FDA Class II designation reflects a risk of temporary health effects from using an affected product; the agency considers the chance of serious harm remote. Under its general guidance, patients can usually continue a medicine subject to a Class II recall unless the FDA or the recalling company gives different directions. The FDA advises patients with questions to consult a doctor or pharmacist. That guidance is not an instruction specific to these lots.
NewLife Rx Team said in an Oct. 19 statement, citing the compounding pharmacy, that the recall was at the retail level and “does not extend to patients or require them to stop using or return their medication.”
Tirzepatide is the active ingredient in the FDA-approved medicines Zepbound and Mounjaro. Because Apothecary Pharma’s injection is compounded, the FDA did not review it before marketing for safety, effectiveness or quality. The FDA says compounding can serve patients whose medical needs cannot be met by an approved medicine.
A Dec. 1, 2025, FDA warning letter described problems found during an inspection that May at Apothecary Pharma’s Cary, North Carolina, facility. The agency cited blocked airflow above open containers and inadequate airflow validation. The FDA’s recall record does not connect those inspection findings to the 2026 action.
