FDA-Drug2026-07-01Class IIPACKAGING DEFECT
BD ChloraPrep Clear skin antiseptic recalled for sterility assurance due to packaging defect
What this means
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.
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 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 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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