Class IIReported 2025-08-13

Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.

Recalled by AEQUITA PHARMACY

Reason for Recall

Lack of Processing Controls.

Recall Number

D-0557-2025

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-07-18

Reported

2025-08-13

Distribution

MA

Code Info

All Lots within expiry.

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.