Class II · ModerateActive recall
Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberAll Lots within expiry.
Where it was soldMA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Lack of Processing Controls.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
| Distributed by / for | AEQUITA PHARMACY |
Show the full FDA record
| Full product label | 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. |
| Recalling firm | AEQUITA PHARMACY |
| Distribution | MA |
| Quantity | 155 vials |
| Recall initiated | 2025-07-18 |
| Report date | 2025-08-13 |
| Recall completed | — |
| Recall number | D-0560-2025 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Kirkland WA United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.