Recalls / Class II
Class IID-0115-2026
Product
Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-04
- Affected lot / code info
- 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
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- ProRx LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 619 Jeffers Cir, N/A, Exton, Pennsylvania 19341-2540
Distribution
- Quantity
- 8,400 vials
- Distribution pattern
- TX and UT
Timeline
- Recall initiated
- 2025-10-15
- FDA classified
- 2025-10-27
- Posted by FDA
- 2025-11-05
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0115-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.