FDAHealthOctober 15, 2025
ProRx LLC — 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
⚠️ Lack of Assurance of Sterility
Is this relevant to me?
- Geography
- TX, UT
- Source agency
- FDA
- Category
- Health
- Published
- October 15, 2025
TX and UT
What's affected?
- 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
- Brand
- ProRx LLC
- Lot code
- PRORX050925-1
Additional details
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
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 8,400 vials.
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