ProRx recalls Semaglutide Injection multidose vials over lack of assurance of sterility
ProRx is recalling its Semaglutide Injection multidose vials in several sizes because the notice cites a lack of assurance of sterility, and they were distributed in TX and UT.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- 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; Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-08; Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial…
- Company
- ProRx LLC
- Hazard
- Lack of Assurance of Sterility
- Units
- 8,400 vials; 8,310 vials; 2,649 vials
- Where sold
- TX and UT
- FDA classification
- Class II · Ongoing
- Classified by FDA
- October 27, 2025
- Recall started
- October 15, 2025
- FDA enforcement report
- November 5, 2025
- Identifiers
- 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
- FDA recall number: D-0115-2026
- Codes: Lot Prorx051425-2, Lot Prorx051425-3 and Lot Prorx051425-4
- FDA recall number: D-0116-2026
- Codes: Lot Prorx051525-5
- FDA recall number: D-0118-2026
- Codes: Lot Prorx051525-1, Prorx051525-2, Prorx051525-3 and Prorx051525-4
- FDA recall number: D-0117-2026
- Codes: Lot PRORX08062025-3
- FDA recall number: D-0120-2026
- Codes: Lot# Prorx04282025-3
- FDA recall number: D-0114-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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 | Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-08 | Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-06 | 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
- Reason for recall
- Lack of Assurance of Sterility
- Classification
- Class II (Ongoing)
- Distribution
- TX and UT
- Quantity
- 8,400 vials; 8,310 vials; 2,649 vials; 11,119 vials; 2,761 vials; 2,809 vials
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