FDA-Drug2026-07-01Class IIPACKAGING DEFECT
BD ChloraPrep FREPP Clear skin antiseptic recalled for potential sterility breach
What this means
BD ChloraPrep FREPP Clear applicators may have wrinkles in the paper lid that could compromise the sterile seal. This affects multiple lot numbers distributed nationwide through mid-2027. No injuries have been reported.
- Check your stock for affected lot numbers (listed on the FDA notice) and expiration dates through October 2027
- Stop using affected applicators and quarantine them
- Contact your distributor or BD for return or replacement instructions
The agency's original wording
Hazard
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Intended for
All ages
Illnesses reported
None reported
Sold states
Nationwide inthe USA, as well as other foreign distribution.
Affected count
N/A
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-0623-2026More 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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