FDA-Drug2026-07-01Class IIPACKAGING DEFECT
BD ChloraPrep Clear skin antiseptic recalled for sterility assurance due to packaging defect
TAMPERINGNationwide distribution
BD ChloraPrep Clear recalled for sterility assurance concern
BD ChloraPrep Clear, a sterile skin antiseptic solution used before medical procedures, is being recalled because wrinkles in the paper packaging lid may allow the sterile seal to be breached. This defect could potentially allow contamination of the product. No injuries have been reported.
- Check if you have BD ChloraPrep Clear applicators with lot numbers and expiration dates listed in the recall notice (June 2026 through May 2027).
- Do not use recalled product; contact your healthcare facility, pharmacy, or BD customer service for replacement or guidance.
- Healthcare facilities should quarantine affected inventory and review usage in medical procedures.
Hazard
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
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 Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators, 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-0622-2026More CareFusion 213, LLC recalls
- FDA-Drug2026-07-01BD ChloraPrep FREPP Clear skin antiseptic recalled for potential sterility breach
- FDA-Drug2026-07-01BD ChloraPrep Clear antiseptic solution recalled for non-sterility due to fungal contamination
- FDA-Drug2026-07-01BD ChloraPrep FREPP Clear skin antiseptic recalled for non-sterility and potential contamination
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