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 |
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.
How to identify the recalled item
| Lot / date codes | Lot PRORX052125-4 |
|---|---|
| Lot / date codes | Lot, Best Use Date (BUD): Lot PRORX050925-1, BUD November 4, 2025; Lot ProRx051425-5, BUD November 10, 2025; Lot ProRx051425-6, BUD November 10, 2025 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
Other semaglutide recalls
- Semaglutide Recall: Northwest Compounders Lot 01-27-2026@14S.5 · 2026-04-22
- Semaglutide Recall: Nomida Lot 241113 and Lot 250103 · 2026-03-11
- Semaglutide Recall: Harbin Jixianglong Biotech CP-030-20250711 · 2026-03-11
- Semaglutide Recall: Wegovy Injection Pens · 2026-01-07
- Semaglutide Recall: Boothwyn Pharmacy 2.5 mg/mL injection · 2025-09-10
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.