PlainRecalls
FDA Drug Moderate Class II Ongoing

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.

Reported: August 13, 2025 Initiated: July 18, 2025 #D-0560-2025

Product Description

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.

Reason for Recall

Lack of Processing Controls.

Details

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

Frequently Asked Questions

What product was recalled?
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.. Recalled by AEQUITA PHARMACY. Units affected: 155 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-0560-2025.