Why it was recalled
Lack of Assurance of Sterility
Product description
Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09
Lot numbers, UPCs & expiration codes
Lot Prorx051525-1, Prorx051525-2, Prorx051525-3 and Prorx051525-4
Where it was sold
TX and UT
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0117-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 15, 2025
- FDA report date
- Nov 5, 2025
- Quantity
- 11,119 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ProRx LLC
Original FDA data
Every field from FDA enforcement report D-0117-2026, exactly as published.
Show all FDA fields
- City
- Exton
- State
- PA
- Status
- Ongoing
- Country
- United States
- Event ID
- 97808
- Address
- 619 Jeffers Cir
- Code information
- Lot Prorx051525-1, Prorx051525-2, Prorx051525-3 and Prorx051525-4
- Postal code
- 19341-2540
- Report date
- Nov 5, 2025
- Product type
- Drugs
- Recall number
- D-0117-2026
- Classification
- Class II
- Recalling firm
- ProRx LLC
- Product quantity
- 11,119 vials
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09
- Distribution pattern
- TX and UT
- Recall initiation date
- Oct 15, 2025
- Initial firm notification
- Letter
- Center classification date
- Oct 27, 2025