Home / Recalls / ProRx LLC / D-0115-2026

D-0115-2026 Class II Ongoing

Recalled by ProRx LLC — Exton, PA

Recall Details

Product Type
Drugs
Report Date
November 5, 2025
Initiation Date
October 15, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8,400 vials

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

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

TX and UT

Code Information

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

Other recalls by ProRx LLC

  • D-0120-2026 Class II — Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneou (October 15, 2025)
  • D-0117-2026 Class II — Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial, For Subcutan (October 15, 2025)
  • D-0118-2026 Class II — Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcutaneo (October 15, 2025)
  • D-0116-2026 Class II — Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcutan (October 15, 2025)
  • D-0119-2026 Class II — Semaglutide Injection, 5 mg/2 mL (2.5 mg/mL), 2mL Multidose Vial, For Subcutaneo (October 15, 2025)
  • D-0114-2026 Class II — Semaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutaneou (October 15, 2025)
  • D-0653-2024 Class II — SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Dr (August 22, 2024)
  • D-0654-2024 Class II — Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL, 2 mL Multiple Dose Vial, (August 22, 2024)
  • D-0655-2024 Class II — TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: ProR (August 22, 2024)
  • D-0650-2024 Class II — Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass via (August 22, 2024)