Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) sub...

FDA Recall #D-0557-2025 — Class II — July 18, 2025

Recall #D-0557-2025 Date: July 18, 2025 Classification: Class II Status: Ongoing

Product Description

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.

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

139 vials

Distribution

MA

Code Information

All Lots within expiry.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated