FDA-Drug2026-07-01Class IPROCESSING DEFECT
BD ChloraPrep FREPP Clear skin antiseptic recalled for non-sterility and potential contamination
What this means
BD ChloraPrep FREPP Clear, a sterile skin antiseptic applicator, may contain fungal contamination (Aspergillus penicillioides) or may not be fully sterile due to wrinkles in the packaging seal. Approximately 178,000 applicators from lot 4073005 (expiring 03/31/2027) are affected nationwide and internationally.
- Do not use affected applicators if you have them in your facility.
- Check your inventory for lot # 4073005.
- Contact your supplier or BD/CareFusion for return or replacement instructions.
- Report any use of affected product or adverse effects to the FDA MedWatch program (1-888-SAFEGUARD or FDA.gov/medwatch).
The agency's original wording
Hazard
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide inthe USA, as well as other foreign distribution.
Affected count
178,000 applicators
Manufactured in
1550 Northwestern Dr, N/A, El Paso, TX, United States
Products
BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0625-2026More 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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