Class II · Moderate risk
Tirzepatide/Niacinamide 2mL vial
Lack of assurance of sterility.
Tirzepatide Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
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.
Affected NDC
85091-0001-18
Compare with the code on your package — it is the most precise check available.
Drug: Tirzepatide
- Recalling firm
- Apothecary Pharma LLC
- NDC code
- 85091-001-18
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0036-2027 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Tirzepatide recalls
See all
Class II · Moderate risk
Tirzepatide/Cyanocobalamin 85/2 Mg/Ml Injectable
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Class II · Moderate risk
Tirzepatide/Cyanocobalamin 76/2 Mg/Ml Injectable
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Class II · Moderate risk
Tirzepatide/Cyanocobalamin 64/2 Mg/Ml Injectable
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Class II · Moderate risk
Tirzepatide/Cyanocobalamin 26/2 Mg/Ml Injectable
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Other recalls by Apothecary Pharma LLC
All 2026 recalls
Class II · Moderate risk
Apothecary NAD+ Injection 200 mg/mL
Lack of Assurance of Sterility
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