Why it was recalled
Lack of Processing Controls.
Product description
Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Lot numbers, UPCs & expiration codes
All Lots within expiry
Where it was sold
MA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0554-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 18, 2025
- FDA report date
- Aug 13, 2025
- Quantity
- 236 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AEQUITA PHARMACY
Original FDA data
Every field from FDA enforcement report D-0554-2025, exactly as published.
Show all FDA fields
- City
- Kirkland
- State
- WA
- Status
- Ongoing
- Country
- United States
- Event ID
- 97292
- Address
- 12825 Ne 126th Pl
- Code information
- All Lots within expiry
- Postal code
- 98034-7721
- Report date
- Aug 13, 2025
- Product type
- Drugs
- Recall number
- D-0554-2025
- Classification
- Class II
- Recalling firm
- AEQUITA PHARMACY
- Product quantity
- 236 vials
- Reason for recall
- Lack of Processing Controls.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
- Distribution pattern
- MA
- Recall initiation date
- Jul 18, 2025
- Initial firm notification
- Center classification date
- Aug 1, 2025