Apothecary Pharma Recalls Tirzepatide Injection Vials Due to Sterility Concerns
Apothecary Pharma LLC is recalling 22 vials of Tirzepatide Injection due to a lack of assurance of sterility. The affected product was distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the source identifies a lack of assurance of sterility as the hazard. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Apothecary Pharma LLC is recalling 22 vials of Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only. The recall is being conducted because of a lack of assurance of sterility in the product. The affected product is identified by NDC 85091-001-18 and includes specific lot numbers with best-use dates ranging from October 2026 to November 2026.
The affected product was distributed nationwide within the United States. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- 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.
- Manufacturer
- Apothecary Pharma LLC
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 22
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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