FDA-Drug2026-07-08Class IIPROCESSING DEFECT

BD ChloraPrep Clear skin antiseptic recalled for lack of sterility assurance

OTHERNationwide distributionDrugs

What this means

BD ChloraPrep Clear applicators (a skin-prep solution containing chlorhexidine and isopropyl alcohol) were distributed without proper sterilization. These applicators were intended to be sterilized before sale but were sent to customers in an unsterilized state. The affected products are in 3 ml applicator packs, with multiple lot numbers expiring between June 2026 and February 2029.

  • Check your ChloraPrep Clear applicators for lot numbers listed in the recall notice.
  • Do not use unsterilized applicators on patients or open wounds.
  • Contact your supplier or BD/CareFusion for instructions on returning or replacing affected units.
  • If you have already used these applicators, consult your infection control team for guidance.
The agency's original wording
Hazard

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

Intended for
Adults
Illnesses reported
None reported
Sold states
Distributed Nationwide in the USA
Affected count
146,600 units
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), Packaged as a) 100 x 3ml applicators/case, NDC 54365-400-32, catalog 930400NS; b) 250 x 3ml applicators/case, NDC 54365-400-32, bulk Catalog 930500NSB, Sterile Solution, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0645-2026

More CareFusion recalls

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