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Drug FDA Class II Ongoing Contamination / non-sterility

BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if package is intact, Flammable, External Use Only, 1 mL Applicator per pouch, 60 Applicators per inner carton, CareFusion 213

CareFusion 213, LLC Published May 28, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact CareFusion 213, LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.

Hazards

Lack of Sterility Assurance - Open Seal · primary

Affected products (1)

BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if package is intact, Flammable, External Use Only, 1 mL Applicator per pouch, 60 Applicators per inner carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., Made in the USA, Catalog Number 930480, NDC 54365-400-31.

CHLORAPREP ONE-STEP · 385,200 applicators

NDC: 54365-400, 54365-400-31
Code info: Lot #s: 3354127 and 3350974, Exp Date: 12/31/2026

Affected areas

Nationwide

Timeline

  1. Initiated
    May 15, 2025
  2. Published
    May 28, 2025
Recall number
D-0441-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.