AEQUITA PHARMACY recalls Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile,…

Recall date

July 18, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0559-2025

FDA classification

Class II

Brand / firm

AEQUITA PHARMACY

Sold / distributed

MA

Why it was recalled

Lack of Processing Controls.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Tirzepatide + Niacinamide 13.2 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.