FDA-Drug2026-07-01Class IPROCESSING DEFECT
BD ChloraPrep Clear antiseptic solution recalled for non-sterility due to fungal contamination
What this means
BD ChloraPrep Clear, a sterile antiseptic skin-prep solution used before medical procedures, was found to contain Aspergillus penicillioides fungus in some applicators. This affects the sterility of the product, which is critical for medical use. The affected lot is Lot #4032183 with an expiration date of January 31, 2027.
- Stop using affected applicators immediately if you have them in your facility.
- Check your inventory for Lot #4032183 (NDC 54365-400-31).
- Contact CareFusion/BD for return or disposal instructions.
- Contact your healthcare provider if this product was used on you or a patient in your care.
The agency's original wording
Hazard
Non-Sterility: Due to presence of Aspergillus penicillioides.
Intended for
All ages
Illnesses reported
None reported
Sold states
Nationwide inthe USA, as well as other foreign distribution.
Affected count
193,440 applicators
Manufactured in
1550 Northwestern Dr, N/A, El Paso, TX, United States
Products
BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Applicators per inner Carton, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-31.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0624-2026More CareFusion recalls
- FDA-Drug2026-07-22BD ChloraPrep Clear skin antiseptic recalled for potential sterility packaging defect
- FDA-Drug2026-07-08BD ChloraPrep Clear skin antiseptic recalled for lack of sterility assurance
- FDA-Drug2026-07-08BD ChloraPrep Hi-Lite Orange recalled for lack of sterility assurance
- FDA-Drug2026-07-08BD ChloraPrep Scrub Teal recalled for lack of sterility assurance
- FDA-Drug2026-07-08BD ChloraPrep Hi-Lite Orange skin antiseptic recalled for lack of sterility assurance
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