ProRx LLC recalls Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffe
Recalled November 5, 2025 · FDA recall D-0120-2026 · ProRx
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
2,761 vials
Sold at
TX and UT
Description
Lack of Assurance of Sterility
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
Manufacturer(s)
ProRx LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →