FDA recall D-0120-2026

ProRx LLC · Class II · drug

Product

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

Reason for recall

Lack of Assurance of Sterility

Distribution

TX and UT

Key facts

Status: Ongoing
Initiation date: 2025-10-15
Report date: 2025-11-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Exton, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0120-2026