Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subc...

FDA Recall #D-0554-2025 — Class II — July 18, 2025

Recall #D-0554-2025 Date: July 18, 2025 Classification: Class II Status: Ongoing

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.

Recalling Firm

AEQUITA PHARMACY — Kirkland, WA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

236 vials

Distribution

MA

Code Information

All Lots within expiry

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated