ProRx LLC recalls Tirzepatide Injection
- Recalling company
- ProRx LLC
- 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
- Lack of Assurance of Sterility
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Oct 15, 2025
- Reported
- Nov 5, 2025
- Distribution
- TX and UT
- Status
- Ongoing
- Quantity
- 2,761 vials
- Lot / codes
- Lot PRORX08062025-3
- Company location
- Exton, PA
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0120-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0120-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.