Elevated risk U.S. Food and Drug Administration

BD ChloraPrep Clear 1 mL applicator skin preparation product recall: Potential for fungal contamination under certain environmental conditions

Recall published 1+ years ago

Potential for fungal contamination under certain environmental conditions allowing the growth of Aspergillus penicillioides

The hazard: Drug safety concern

The product was withdrawn from distribution. Whether your own pack is affected comes down to the lot number.

What the notice says: Since the applicator is used for site preparation prior to an invasive procedure, a contaminated applicator can result in direct inoculation of the fungus into tissues.

Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.

Recall details

Published
February 15, 2025
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
BD
Product type
Prescription & OTC drugs
Reports of harm
To date, there have been no reported customer complaints or adverse events associated with this issue.

Products covered by this recall

ChloraPrep Clear 1 mL applicator skin preparation product

What the company announced

FRANKLIN LAKES, N.J. (Feb. 15, 2025) – BD (Becton, Dickinson and Company) today announced the voluntary recall of one lot of ChloraPrep™ Clear 1 mL Applicators due to fungal contamination under certain environmental conditions allowing the growth of Aspergillus penicillioides.

The Aspergillus penicillioides within the packaging can contaminate the surface of the applicator and/or gloved hands of the health care professional and then consequently the sterile field. Since the applicator is used for site preparation prior to an invasive procedure, a contaminated applicator can result in direct inoculation of the fungus into tissues. This lot was distributed globally beginning in September 2023. To date, there have been no reported customer complaints or adverse events associated with this issue.

Risk Statement: Contamination of skin preparation products with Aspergillus penicillioides may lead to serious systemic infection, sepsis, illness, and death. If the fungus is introduced in the patient’s bloodstream during placement of an intravascular catheter, the catheter would most likely have to be removed, necessitating another procedure. Aspergillus penicillioides infection of a surgical site may result in the need for medical and surgical interventions and long-term treatment with antifungal drugs.

The product is used for the preparation of the patient’s skin prior to surgery, helps to reduce bacteria that potentially can cause skin infection, and is packaged in a pouch (1 applicator per pouch, 60 applicators per inner carton).

  • Affected Product NDC: 54365-400-31 · Product Name: BD ChloraPrep™ Clear - 1 mL Applicator · Catalog (REF) Number: 930480 · Lot Number: 3200240 · Expiry Date: 6/30/2026 · Product Package Size: 60 Applicators per Inner Carton 4 Inner Cartons per Case

The affected lot (3200240) can be identified by locating the above referenced catalog and lot number on the lidding of the product package and the side of the individual shelf box and shipper box. Please immediately discontinue use of the affected lot. Check all inventory locations within your facility and destroy all affected units in accordance with your facility’s process. If destruction is not immediately possible at your facility, then product should be quarantined until disposal.

This recall should be carried out to the Distributor, Hospital and User levels. BD is instructing distributors to identify all customers within their distribution network who may have purchased any of the affected product listed.

Customer inquiries related to this recall, as well as adverse reaction/events experienced with the product, should be addressed to BD’s Complaint Center: 1-844-823-5433 (Toll Free) Monday – Friday between the hours of 9 a.m. and 6 p.m. ET or by emailing: [email protected] .

The U.S. Food and Drug Administration (FDA) has been notified of this recall.

FDA MedWatch Reporting

Adverse reactions/events experienced with the use of any of these products should also be reported to the FDA's MedWatch Adverse Event Reporting program either online, phone or by regular mail.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm

Call 1-800-FDA-1088 (1-800-332-1088) • Regular Mail: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.

About BD

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its more than 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com or connect with us on LinkedIn at www.linkedin.com/company/bd1/ , X (formerly Twitter) @BDandCo or Instagram @becton_dickinson .

Media: Investors:

Troy Kirkpatrick Adam Reiffe

BD Public Relations BD Investor Relations

858.617.2361 201.847.6927

[email protected] [email protected]

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 5 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 3200240

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 6/30/2026

NDC number

On the carton and again on the bottle or blister label.

  • 54365-400-31

Model or item number

On the rating label, the box or the instruction sheet.

  • NDC 54365-400-31

Package size

Match the net weight or the piece count on the front of the pack.

  • 1 mL

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Drug safety

BD — The product was withdrawn from distribution. Whether your own pack is affected comes down to the lot number.

  1. Check the lot number on your pack against the codes listed above.
  2. Do not stop a prescribed medicine on your own — speak to your prescriber or pharmacist first.
  3. Ask the dispensing pharmacy for a replacement from an unaffected lot.
  4. Keep the carton; the lot number is often printed only on the outer pack.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Remedy named in the notice: Check all inventory locations within your facility and destroy all affected units in accordance with your facility’s process.

Company contact: BD — Consumers: BD’s Complaint Center, 1-844-823-5433, [email protected] — Media: Troy Kirkpatrick, BD Public Relations, 858.617.2361, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was BD prescription & otc drugs recalled?

Potential for fungal contamination under certain environmental conditions allowing the growth of Aspergillus penicillioides Since the applicator is used for site preparation prior to an invasive procedure, a contaminated applicator can result in direct inoculation of the fungus into tissues.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 3200240; best-by date 6/30/2026; model number NDC 54365-400-31. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Check the lot number on your pack against the codes listed above.

Can I get my money back?

The notice says: Check all inventory locations within your facility and destroy all affected units in accordance with your facility’s process.

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