FDA recall D-0554-2025

Product

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.

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-0554-2025