Lower risk Drug recall · FDA · Published April 22, 2026

BD PurPrep Sterile Solution Recall: Potential Contamination Risk

CareFusion recalls BD PurPrep povidone-iodine solution due to potential contamination. Affected lots expire 08/31/2026 to 10/31/2026. Stop using if you have these specific lots.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0518-2026Drug BD PurPrep ›

Lower-risk recall

Lack of assurance of Sterility: potential product contamination

Take action

Contact the company

Recalling firmCareFusion 213, LLC1550 Northwestern Dr · El Paso, TX 79912-8000

✎ GovInfoNow plain-language explainer

CareFusion is recalling BD PurPrep povidone-iodine solution because it may not be sterile, which could lead to contamination. This affects specific lots with expiration dates through October 2026. The recall is for safety reasons to prevent potential infections. Read more at govinfonow.com/recall/31339-bd-purprep-sterile-solution-recall-potential-contamination-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/31339-bd-purprep-sterile-solution-recall-potential-contamination-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0518-2026

Cite this page

“BD PurPrep Sterile Solution Recall: Potential Contamination Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31339-bd-purprep-sterile-solution-recall-potential-contamination-risk. Based on FDA recall #D-0518-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0518-2026%22&limit=1).

The FDA announced on April 22, 2026, that CareFusion 213, LLC is recalling BD PurPrep sterile solution due to a lack of sterility assurance. The agency classified the recall as Class II.

How to tell if you have it

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
NDC 54365-014-41
Lots# 4263873, Exp. Date 08-31-2026
4320590, Exp. Date 09-30-2026
4320591, Exp. Date 10-31-2026

The hazard

The recall addresses a potential product contamination resulting from a lack of assurance of sterility in the sterile solution.

Context

GovInfoNow's records show CareFusion 213, LLC has 16 other recalls on record since 2011-11-08. Other recent recalls of similar products include BD ChloraPrep Clear 60x1mL (2026-07-09), BD ChloraPrep Applicators (2026-06-11), and CareFusion BD ChloraPrep FREPP Clear 1.5mL Applicator (2026-05-28). Other recent recalls of similar products include Reliance Pemetrexed Injection (2026-06-24), American Regent Epinephrine Injection (2026-08-11), and ProRx Semaglutide Injection (2025-10-15).

How to tell if you have this one

Check the lot number on the packaging, which is listed as 4263873 (expiring 08/31/2026), 4320590 (expiring 09/30/2026), or 4320591 (expiring 10/31/2026). The product comes in 0.36 fl. oz. (10.5 mL) per box with 25 applicators.

Brand
BD PurPrep
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Nationwide in the USA
NDC
54365-014-42, 54365-014-41

Recall number	Product, codes & lots	Quantity
D-0517-2026	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.; 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.	—
D-0518-2026	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; Lots# 4263873, Exp. Date 08-31-2026, 4320590, Exp. Date 09-30-2026, 4320591, Exp. Date 10-31-2026.	—

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for the lot number on the packaging: 4263873, 4320590, or 4320591.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 21 days after the firm started it.

Apr 22, 2026Firm started the recall
May 5, 2026FDA classified it Class II
May 13, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other BD PurPrep recalls

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/31339-bd-purprep-sterile-solution-recall-potential-contamination-risk">BD PurPrep Sterile Solution Recall: Potential Contamination Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0518-2026 (April 22, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0518-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.