Class II · Moderate risk
Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol
Lack of Processing Controls.
Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Processing Controls.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Drug: Niacinamide
- Recalling firm
- Aequita Pharmacy
- Origin
- WA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0557-2025 · 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 Niacinamide recalls
See all
Class II · Moderate risk
Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol
Lack of Processing Controls.
Class II · Moderate risk
Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol
Lack of Processing Controls.
Class II · Moderate risk
Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol
Lack of Processing Controls.
Class II · Moderate risk
Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol
Lack of Processing Controls.
Other recalls by Aequita Pharmacy
All 2025 recalls
Class II · Moderate risk
Semaglutide + Cyanocobalamin 2.67 mg + 0.25mg/0.5 mL Inj Sol
Lack of Processing Controls.
Class II · Moderate risk
Semaglutide + Cyanocobalamin injection solution
Lack of Processing Controls.
Class II · Moderate risk
Semaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol
Lack of Processing Controls.
Class II · Moderate risk
Semaglutide + Cyanocobalamin 0.88 mg + 0.25mg/0.5 mL Inj Sol
Lack of Processing Controls.
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