Recall
FDAHealthOctober 15, 2025

ProRx LLC — Semaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09

⚠️ 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, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09
Lot code
Prorx04282025-3

Additional details

Lot# Prorx04282025-3

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 2,809 vials.

View original FDA notice →

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