FDAFDA · Food and drugs·Recall number D-0120-2026
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
Published November 5, 2025 · Recall initiated: October 15, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ProRx LLC
- Distributor
- TX and UT
- Lot
- Lot PRORX08062025-3
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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