Compounded tirzepatide and niacinamide vials recalled over lack of processing controls
Tirzepatide + Niacinamide 2.2 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 236 vials are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Risk-of-harm product: a sterile injectable compounded without adequate processing controls, with no infection or injury reported in the source.
Plain-English summary
Tirzepatide + Niacinamide, 2.2 mg + 1.0 mg per 0.5 mL injection solution, for subcutaneous injection, sterile, supplied in a 2 mL multi dose vial to be refrigerated and not frozen, compounded by Aequita Pharmacy LLC of Kirkland, Washington, is being recalled. The action covers 236 vials across all lots within expiry.
The stated reason is a lack of processing controls. The FDA classified the action as Class II. The source does not report any infection or injury.
Distribution was in Massachusetts.
Facilities and patients holding affected vials should stop using them and follow the instructions issued by the compounder.
The recalled product
- Product
- 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.
- Manufacturer
- AEQUITA PHARMACY
- Category
- Drug — Compounded injectable
- Affected units
- 236
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots within expiry
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 13 recalled by AEQUITA PHARMACY under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 13 products in this recall →Related recalls
Same manufacturer · AEQUITA PHARMACY
See all →- HighCompounded semaglutide 0.22 mg vials recalled over lack of processing controls
FDA (Drugs) · 2025-08-13
- HighCompounded tirzepatide 4.4 mg vials recalled over lack of processing controls
FDA (Drugs) · 2025-08-13
- HighCompounded semaglutide 1.5 mg vials recalled over lack of processing controls
FDA (Drugs) · 2025-08-13
- HighCompounded tirzepatide 11.24 mg vials recalled over lack of processing controls
FDA (Drugs) · 2025-08-13
- HighCompounded semaglutide 0.44 mg vials recalled over lack of processing controls
FDA (Drugs) · 2025-08-13
Same hazard · processing controls
See all →- HighCompounded tirzepatide 8.8 mg vials recalled over lack of processing controls
FDA (Drugs) · 2025-08-13
- HighCompounded tirzepatide 16.6 mg vials recalled over lack of processing controls
FDA (Drugs) · 2025-08-13