FDA-Drug2026-10-14Class IIPROCESSING DEFECT
Apothecary Pharma Tirzepatide Injection recalled for lack of sterility assurance
What this means
Apothecary Pharma LLC is recalling Tirzepatide Injection 18mg/mL vials because the manufacturer cannot guarantee the product is sterile. The affected vials were distributed nationwide. No infections or injuries have been reported so far.
- If you have a vial matching one of the recalled lot numbers (AP-202622 through AP-202644), do not use it.
- Contact your pharmacy or healthcare provider for a replacement or alternative.
- Ask your provider or pharmacist if you need to repeat any doses you may have already taken from an affected vial.
The agency's original wording
Hazard
Lack of Assurance of Sterility
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the United States
Affected count
22 vials
Manufactured in
1913 Evans Rd, N/A, Cary, NC, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0036-2027More Apothecary Pharma recalls
- FDA-Drug2026-10-14Apothecary NAD+ Injection recalled for lack of sterility assurance
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