CLASS II ONGOING Drug recall · Reported 13 May 2026 · FDA Enforcement Report

BD PurPrep, Povidone-iodine 8.3% w/w recalled by CareFusion 213

CareFusion 213 is recalling BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol, distributed nationwide in the US. The recall was initiated on 22 Apr 2026 and the FDA has classified it as Class II.

Check your package

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

NDC54365-014

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0517-2026
FDA event ID: 98790
Recalling firm: CareFusion 213, El Paso, TX
Brand: Purprep
Manufacturer: CareFusion 213 LLC
Classification: Class II
Status: Ongoing
Recall initiated: 22 Apr 2026
FDA classified: 5 May 2026
Reported: 13 May 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility

Timeline

22 Apr 2026	Recall initiated by company
5 May 2026	Classified by FDA	+13 days
13 May 2026	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of assurance of Sterility: potential product contamination

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

Lack of assurance of Sterility: potential product contamination

Which lots are affected?

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.

Where was it sold?

Nationwide in the USA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 98790

This product is part of a recall event; the main page for the event is BD PurPrep, Povidone-iodine 8.3% w/w recalled by CareFusion 213.

Reported	Class	Recall	Company	Reason	Where
13 May 2026	CLASS II	BD PurPrep, Povidone-iodine 8.3% w/w recalled by CareFusion 213Purprep	CareFusion 213	Sterility	Nationwide

More recalls from CareFusion 213

All 48

Reported	Class	Recall	Company	Reason	Where
22 Jul 2026Drug	CLASS II	BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate recalledChloraprep One-step	CareFusion 213	Sterility	Nationwide
8 Jul 2026Drug	CLASS II	BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) recalledChloraprep One-step	CareFusion 213	Sterility	Nationwide
8 Jul 2026Drug	CLASS II	BD ChloraPrep Hi-Lite Orange recalled by CareFusion 213Chloraprep One-step	CareFusion 213	Sterility	Nationwide
8 Jul 2026Drug	CLASS II	BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate recalledChloraprep One-step	CareFusion 213	Sterility	Nationwide
8 Jul 2026Drug	CLASS II	BD ChloraPrep Hi-Lite Orange recalled by CareFusion 213Chloraprep One-step	CareFusion 213	Sterility	Nationwide

Other Povidone Iodine recalls

All 15

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Drug	CLASS III	Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic recalled	ImprimisRx NJ	Potency & Assay	Nationwide
8 Jul 2026Drug	CLASS II	BD PurPrep, (Povidone-iodine 8.3% w/w recalled by CareFusion 213Purprep	CareFusion 213	Sterility	Nationwide
1 Jul 2026Drug	CLASS II	Povi-One, 10% Povidone-Iodine Oral Antiseptic recalledPovi-one	Elevate Oral Care	Potency & Assay	Nationwide
13 May 2026Drug	CLASS II	BD PurPrep, Povidone-iodine 8.3% w/w recalled by CareFusion 213Purprep	CareFusion 213	Sterility	Nationwide
1 Oct 2025Drug	CLASS III	Readyprep PVP, Povidone-Iodine 10% Solution recalledPovidone-iodine	Medline Industries	Potency & Assay	Nationwide