RecallRadar
ModerateReported May 13, 2026 (7 weeks ago)

BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with…

Recalled by CareFusion 213, LLC

Product image for 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
Product image via DailyMed (National Library of Medicine). It may show general packaging and not the exact recalled lot — always confirm using the codes below.

Class II — moderate

Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

CareFusion 213, LLC has recalled BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with…, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on May 13, 2026 and was initiated on April 22, 2026. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with…. The company behind the recall is CareFusion 213, LLC, based in El Paso, TX. The FDA describes the product as: “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”

Why was BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with… recalled?

According to the FDA, the stated reason for the recall is: “Lack of assurance of Sterility: potential product contamination.” In plain terms, this recall relates to a sterility or contamination concern.

Sterile medicines, such as injectables and eye drops, must be completely free of microorganisms and stray particles. This recall means that sterility could not be assured or that contamination was found or suspected. Using a non-sterile product of this kind can cause infections, which is why these recalls are treated seriously.

What should you do?

If you think you may have bought BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with…, compare it against the product description and identifying codes (Lots# 4263873, Exp. Date 08-31-2026, 4320590, Exp. Date 09-30-2026, 4320591, Exp. Date 10-31-2026.) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact CareFusion 213, LLC or your local health authority.

About this recall

This recall was distributed in TX. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.

Full recall details

Status
Ongoing
Date reported
May 13, 2026
Recall started
April 22, 2026
Distributed in
TX
What was recalled
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
Why it was recalled (as stated by the FDA)
Lack of assurance of Sterility: potential product contamination
How to identify the affected product
Lots# 4263873, Exp. Date 08-31-2026, 4320590, Exp. Date 09-30-2026, 4320591, Exp. Date 10-31-2026.

What you can do

Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.

Quick answers

Why was BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with… recalled?+

According to the FDA: Lack of assurance of Sterility: potential product contamination

How serious is this recall?+

Class II — moderate. Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

What should I do if I have BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with…?+

Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.

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View the official FDA record

Opens the U.S. Food and Drug Administration (FDA) data for this recall.

Recall number: D-0518-2026. Information last synced from the FDA on July 6, 2026.

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