Class II · ModerateActive recall
Semaglutide Injection
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot PRORX052125-4
Where it was soldTX and UT
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Lack of Assurance of Sterility
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
| Distributed by / for | ProRx LLC |
| NDC | 84139-225-02 |
Show the full FDA record
| Full product label | 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 |
| Recalling firm | ProRx LLC |
| Distribution | TX and UT |
| Quantity | 2,805 vials |
| Recall initiated | 2025-10-15 |
| Report date | 2025-11-05 |
| Recall completed | — |
| Recall number | D-0119-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Exton PA United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.