FDAClass II · Drug · Recalled May 13, 2026

BD PurPrep recall — CareFusion 213, LLC

Hazard: Lack of assurance of Sterility: potential product contamination

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0518-2026
Brand: CareFusion 213
Classification: Class II
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x 25 applicators per box. Carefusion 213, LLC, El Paso, TX 79912, subsidary of Becton Dickinson and Co. NDC 54365-014-41

Affected products

BD PurPrep

Companies & origin

Recalling firm location: El Paso, TX, United States
Firm address: 1550 Northwestern Dr, 79912-8000

Identifying details (verbatim from the notice)

Product codes / lots: Lots# 4263873, Exp. Date 08-31-2026, 4320590, Exp. Date 09-30-2026, 4320591, Exp. Date 10-31-2026.
Distribution: Nationwide in the USA
Firm notified the public via: Letter
FDA event ID: 98790
Recall initiated: April 22, 2026
FDA classified: May 5, 2026
FDA report date: May 13, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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