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-0517-2026
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, 25x26mL Applicators per carton. Carefusion 213 LLC, El Paso, TX 79912, NDC 54365-014-42.

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: Lot# 4258309, 4260329, 4256875, Exp. Date, 08-31-2026; 4296453, 4317319, 4290654, Exp. Date 09-30-2026; 4322449, 4323861, 4318679, Exp Date 10-31- Exp.
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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