ProRx LLC

Drugs recall · D-0115-2026

Reason for recall

Lack of Assurance of Sterility

Product description

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

Recalling firm

ProRx LLC

Product quantity

8,400 vials

Lot / 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

Distribution

TX and UT

Recall initiated

2025-10-15

Status

Ongoing

Location

Exton, PA, United States

Voluntary / mandated

Voluntary: Firm initiated

Initial notification

Letter

Data from official federal safety records. Updated periodically. Verify on FDA.gov