FDA-Drug2026-07-22Class IIPACKAGING DEFECT
BD ChloraPrep Clear skin antiseptic recalled for potential sterility packaging defect
What this means
BD ChloraPrep Clear, a sterile skin antiseptic solution used before medical procedures, may have open or incomplete seals on individual applicator packaging. This could allow contamination of the sterile product. The issue affects multiple lot numbers distributed nationwide.
- Check if you have BD ChloraPrep Clear applicators with lot numbers listed in this recall (check your carton)
- Do not use applicators from affected lots if the seal appears open or incomplete
- Contact your medical facility or supplier about replacement stock
- Report any suspected use of affected product to your healthcare provider
The agency's original wording
Hazard
Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S.A. Nationwide
Affected count
43,066,599 units
Manufactured in
1550 Northwestern Dr, El Paso, TX, United States
Products
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL) each, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-31
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0690-2026More CareFusion recalls
- 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
- FDA-Drug2026-07-08BD PurPrep povidone-iodine applicators recalled for lack of sterility assurance
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