Highest risk U.S. Food and Drug Administration

BD ChloraPrep Clear – 1 mL Applicators and ChloraPrep FREPP Clear 1.5 mL recall: Potential fungal contamination under certain environmental conditions

Recall published 5 months ago

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

The hazard: Microbial contamination

The problem here is microbial contamination, so the recall covers the production codes listed rather than the brand as a whole.

What the notice says: Risk Statement: Contamination of skin preparation products with Aspergillus penicillioides may lead to serious systemic infection, sepsis, illness, and death.

Why it matters: The product was found, or is suspected, to carry a harmful micro-organism. The agency notice names the specific organism and that detail matters, because the illness it causes and the people most at risk differ from one to the next.

Symptoms and when to call a doctor

Most foodborne infections cause stomach cramps, diarrhoea, nausea and sometimes fever, starting anywhere from hours to weeks after exposure depending on the organism. See a doctor for a high fever, bloody diarrhoea, vomiting that stops you keeping liquids down, diarrhoea lasting more than three days, or signs of dehydration. Infants, pregnant people, adults over 65 and anyone immunocompromised should seek advice earlier.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
June 6, 2026
Risk level
Highest risk
Issued by
U.S. Food and Drug Administration
Brand
BD
Product type
Prescription & OTC drugs

Products covered by this recall

ChloraPrep Clear – 1 mL Applicators and ChloraPrep FREPP Clear 1.5 mL Applicators

What the company announced

FRANKLIN LAKES, N.J. (June 06, 2026) – BD (Becton, Dickinson and Company) is voluntarily recalling lot 4032183 of ChloraPrep™ Clear 1 mL Single Sterile and lot 4073005 of FREPP™ Clear 1.5 mL applicators with paper lidding to the consumer level. These products are being recalled due to fungal contamination under certain environmental conditions allowing the growth of Aspergillus penicillioides.

These two impacted lots were shipped to distributors and hospitals between March 2024 through June 2024.

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. Importantly, BD has not received any reports of adverse events related to this recall.

  • Affected Product NDC: 54365-400-31 · Product Name: BD ChloraPrep™ Clear - 1 mL Applicators · Catalog (REF) Number: 930480 · Lot Number: 4032183 · Expiry Date: 01/31/2027 · Product Package Size: 60 Applicators per Inner Carton
  • Affected Product NDC: 54365-400-30 · Product Name: BD ChloraPrep™ FREPP™ Clear 1.5 mL Applicators · Catalog (REF) Number: 930299 · Lot Number: 4073005 · Expiry Date: 03/31/2027 · Product Package Size: 20 Applicators per Inner Carton

In addition, BD is recalling other lots out of an abundance of caution as outlined in the customer letter .

These products are packaged in a pouch with paper lidding and used for the preparation of the patient’s skin prior to procedures, to help reduce bacteria that potentially can cause skin infection.

The affected lots can be identified by locating the referenced catalog and lot numbers on the lidding of the product package and the side of the inner carton as shown in the customer letter.

BD is notifying its customers and distributors who received this product directly. Customers and distributors should immediately discontinue use of and destroy all affected units in accordance with their facility’s process.

BD will issue replacement for destroyed product of the affected lot numbers to customers that purchased the affected product directly from BD, following receipt of the completed Customer Response Form.

Customer inquiries related to this recall, as well as adverse reaction/events experienced with the product, should be addressed to BD’s North American Regional Complaint Center: 1-844-823-5433 (Toll Free) Monday – Friday between the hours of 8a.m. and 5 p.m. CT or by emailing: [email protected] .

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 : MedWatch, HF-2, FDA, 5600 Fisher’s Lane, Rockville, MD 20852-9787

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

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About BD

BD is one of the world’s largest pure-play medical technology companies with a Purpose of advancing the world of health™ by driving innovation across medical essentials, connected care, biopharma systems and interventional. The company supports those on the frontlines of healthcare by developing transformative technologies, services and solutions that optimize clinical operations and improve care for patients. Operating across the globe, with more than 60,000 employees, BD delivers billions of products annually that have a positive impact on global healthcare. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase clinical efficiency, improve safety and expand access to healthcare. For more information on BD, please visit bd.com or connect with us on LinkedIn at www.linkedin.com/company/bd1/ , X @BDandCo or Instagram @becton_dickinson .

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 10 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.

  • 4032183
  • 4073005

Best-by / use-by date

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

  • 01/31/2027
  • 03/31/2027

NDC number

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

  • 54365-400-31
  • 54365-400-30

Model or item number

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

  • NDC 54365-400-31
  • NDC 54365-400-30

Package size

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

  • 1 mL
  • 1.5 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 Contamination

BD — The problem here is microbial contamination, so the recall covers the production codes listed rather than the brand as a whole.

  1. Stop eating it and keep it separate from other food.
  2. If anyone who ate it is unwell, mention the recall and the date by name when you call a clinician.
  3. Bag and bin it, or return it to the store for a refund.
  4. Clean and sanitise the fridge shelf, container or surface it was stored on.

Refunds, and what else you can claim

The purchase price is the floor, not the ceiling. Where a recall caused you a real cost, say so.

  • Claim the refund at the store first; it is the fastest route and needs the least paperwork.
  • If you bought several packs over time, list them. Firms routinely settle for more than a single unit when a customer asks.
  • Medical costs, lost earnings or a spoiled event are not handled at the service desk. Write to the company contact on this page instead, with dates and documents.
  • Keep copies of everything you send. If a recall caused harm, that file is what any later claim rests on.

Remedy named in the notice: Customers and distributors should immediately discontinue use of and destroy all affected units in accordance with their facility’s process.

Company contact: BD — Consumers: BD’s North American Regional Complaint Center, 1-844-823-5433, [email protected] — Media: Matt Marcus, VP, Public Relations, [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 fungal contamination under certain environmental conditions allowing the growth of Aspergillus penicillioides Risk Statement: Contamination of skin preparation products with Aspergillus penicillioides may lead to serious systemic infection, sepsis, illness, and death.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 4032183, 4073005; best-by date 01/31/2027 or 03/31/2027; model number NDC 54365-400-31, NDC 54365-400-30. 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?

Stop eating it and keep it separate from other food.

Can I get my money back?

The notice says: Customers and distributors should immediately discontinue use of and destroy all affected units in accordance with their facility’s process.

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