Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, M...
FDA Recall #D-0120-2026 — Class II — October 15, 2025
Product Description
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
Recalling Firm
ProRx LLC — Exton, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
2,761 vials
Distribution
TX and UT
Code Information
Lot PRORX08062025-3
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated