FDA recall D-0558-2025

Product

Tirzepatide + Niacinamide 11.24 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.

Distribution

MA

Key facts

Status

Ongoing

Initiation date

2025-07-18

Report date

2025-08-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Kirkland, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0558-2025