Recall archive / FDA company announcement

BD: ChloraPrep Clear 1 mL applicator skin preparation product — FDA announcement Feb 18, 2025

Published notice; closure not supplied

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Feb 18, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: ChloraPrep Clear 1 mL applicator skin preparation product
Reason: Potential for fungal contamination under certain environmental conditions allowing the growth of Aspergillus penicillioides
Classification: Not supplied
Recalling firm: BD
Quantity: Not supplied
Agency-reported status: Company recall announcement
Source record identifier: ecaeb4ed0350c546

Open the official record

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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.; 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.; Affected Product NDC \| Product Name \| Catalog (REF) Number \| Lot Number \| Expiry Date \| Product Package Size; 54365-400-31 \| BD ChloraPrep™ Clear - 1 mL Applicator \| 930480 \| 3200240 \| 6/30/2026 \| 60 Applicators per Inner Carton 4 Inner Cartons per Case

Label field

Details supplied by the agency

Lot, code or applicability

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

Match all identifying details in the current notice. A brand name alone is not enough.

Product tables from the announcement

These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.

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

Announcement retrieved Oct 1, 2026. Official announcement.

Distribution

Not supplied

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Fda listing date: Feb 18, 2025
Company announcement date: Feb 15, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.