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
Reported: November 5, 2025 Initiated: October 15, 2025 #D-0119-2026
Product Description
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
Reason for Recall
Lack of Assurance of Sterility
Details
- Recalling Firm
- ProRx LLC
- Units Affected
- 2,805 vials
- Distribution
- TX and UT
- Location
- Exton, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by ProRx LLC. Units affected: 2,805 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 5, 2025. Severity: Moderate. Recall number: D-0119-2026.
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