FDA Drugs recall ·
Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol… recall
- Recall number
- D-0560-2025
- Date
- (initiated July 18, 2025)
- Company / brand
- Aequita Pharmacy
12825 Ne 126th Pl, Kirkland, WA, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 155 vials
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 3 x 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Why was it recalled?
Lack of Processing Controls.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
All Lots within expiry.
Distribution
MA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0560-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.