Tirzepatide Injection recalled over sterility concerns

Recall date

October 15, 2025

Source

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

Official notice title

ProRx LLC recalls Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeff…

Recall number

D-0120-2026

FDA classification

Class II

Brand / firm

ProRx LLC

Sold / distributed

TX and UT

Why it was recalled

Lack of Assurance of Sterility

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 Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-209-03