Apothecary Pharma Llc: Tirzepatide Injection, 18mg/ml

Apothecary Pharma LLC is recalling Tirzepatide Injection 18mg/mL (a diabetes and weight-loss medication) because the company cannot confirm the product is sterile. The recall affects vials distributed nationwide across all U.S. states and Washington, D.C. This is a Class II recall, meaning use of the product could cause serious health problems.

Recalling firm
Apothecary Pharma LLC
Product
Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC 27513, NDC 85091-001-18.
Reason
Lack of Assurance of Sterility
Classification
Class II
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-09-24
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
Nationwide within the United States

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/bacd7ed1-0bb5-493a-8196-1c52779497fc