Recalls / Class II
Class IID-0556-2025
Product
Tirzepatide + Niacinamide 6.6 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.
- Affected lot / code info
- All Lots within expiry.
Why it was recalled
Lack of Processing Controls.
Recalling firm
- Firm
- AEQUITA PHARMACY
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 12825 Ne 126th Pl, N/A, Kirkland, Washington 98034-7721
Distribution
- Quantity
- 160 vials
- Distribution pattern
- MA
Timeline
- Recall initiated
- 2025-07-18
- FDA classified
- 2025-08-01
- Posted by FDA
- 2025-08-13
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0556-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.