Recall
FDAHealthOctober 15, 2025

ProRx LLC — 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

⚠️ 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, 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 code
Prorx051525-1

Additional details

Lot Prorx051525-1, Prorx051525-2, Prorx051525-3 and Prorx051525-4

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 11,119 vials.

View original FDA notice →

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