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FDAFDA · Food and drugs·Recall number D-0644-2026

BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w), 50 x 26 mL Applicator/case, STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co, Catalog Number 960120NSB; NDC 54365-014-42.

Published July 8, 2026 · Recall initiated: June 11, 2026

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand
PURPREP
Manufacturer
CareFusion 213, LLC
Distributor
Distributed Nationwide in the USA
Lot
Lot: 4298581, expires: 09/30/2026.
Risk classification
Class II
Area (FDA)
drug
Country
United States

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