PlainRecalls
FDA Drug Moderate Class II Ongoing

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.

Reported: August 13, 2025 Initiated: July 18, 2025 #D-0554-2025

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.

Reason for Recall

Lack of Processing Controls.

Details

Recalling Firm
AEQUITA PHARMACY
Units Affected
236 vials
Distribution
MA
Location
Kirkland, WA

Frequently Asked Questions

What product was recalled?
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.. Recalled by AEQUITA PHARMACY. Units affected: 236 vials.
Why was this product recalled?
Lack of Processing Controls.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 13, 2025. Severity: Moderate. Recall number: D-0554-2025.