Class IIReported 2025-11-05

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

Recalled by ProRx LLC

Reason for Recall

Lack of Assurance of Sterility

Recall Number

D-0115-2026

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-10-15

Reported

2025-11-05

Distribution

TX and UT

Code Info

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

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.