Tirzepatide Injection 18 mg/mL Recall: Sterility Concern
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.
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was Tirzepatide Injection 18 mg/mL recalled?
Lack of Assurance of Sterility
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Which lot codes, UPCs or models are affected?
Lot #: AP-202622, BUD 07-Oct-2026; AP-202623, BUD 08-Oct-2026; AP-202624, BUD 19-Oct-2026; AP-202625, BUD 10/20/2026; AP-202627, BUD 10/26/2026; AP-202628, BUD 10/27/2026; AP-202629, BUD 10/28/2026; AP-202630, BUD 10/31/2026; AP-202631, BUD 11/01/2026; AP-202632, BUD 11/03/2026; AP-202633, BUD 11/07/2026; AP-202634, BUD 11/08/2026; AP-202635, BUD 11/16/2026; AP-202636, BUD 11/17/2026; AP-202637,BUD 11/18/2026; AP-202638, BUD 11/19/2026; AP-202639, BUD 11/20/2026; AP-202640, BUD 11/21/2026;AP-202641, BUD 11/22/2026; AP-202642, BUD 11/24/2026; AP-202643, BUD 11/25/2026; AP-202644, BUD 11/26/2026
- Agency record number
- D-0036-2027
- 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.
- Recalling firm
- Apothecary Pharma LLC
- Quantity
- 22 vials
- Distribution
- Nationwide within the United States
- Recall started
- September 24, 2026
- Report date
- October 14, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)