Semaglutide Recall: ProRx 2 mL Multidose Vial
Announced 2025-11-05 · FDA
The FDA recalls ProRx Semaglutide Injection, 5 mg/2 mL, 2 mL multidose vials (Rx Only) due to lack of assurance of sterility. Lot PRORX052125-4, containing 2,805 vials, was distributed in Texas and Utah. Corrective action information is not provided in the notice.
| Brand | ProRx LLC |
|---|---|
| Product | Semaglutide Injection, 5 mg/2 mL (2.5 mg/mL), 2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-02 |
| Reason | Lack of Assurance of Sterility |
| Severity | moderate |
| Units affected | 8400 |
| Distribution | TX and UT |
| Agency | FDA |
| Recall / campaign no. | Lot PRORX052125-4 |
WHAT YOU SHOULD DO
- Do not use recalled vials.
- Check the lot number PRORX052125-4 on your vial to see if you are affected.
- Contact your healthcare provider or pharmacist for guidance and possible replacement.
- Follow the recall instructions from FDA and ProRx for returning or disposing of the recalled product.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.