Skip to content
Back to recalls
Drug FDA Class I Ongoing Contamination / non-sterility

BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Applicators per Carton, CareFusion 213, LLC, El Paso, TX 79912, Subsidiary of Becton, Dickinson and Co.,

CareFusion 213, LLC Published Mar 19, 2025

Risk level

Class I

Dangerous or defective — could cause serious health problems or death.

Severity score 85/100

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

Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.

Hazards

Aspergillus penicillioides · primary

Affected products (1)

BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Applicators per Carton, CareFusion 213, LLC, El Paso, TX 79912, Subsidiary of Becton, Dickinson and Co., REF 930480, NDC 54365-400-31.

CHLORAPREP ONE-STEP · 205,440 applicators

NDC: 54365-400, 54365-400-31
Code info: Lot #: 3200240, Exp 6/30/2026

Affected areas

Nationwide

Timeline

  1. Initiated
    Feb 14, 2025
  2. Published
    Mar 19, 2025
Recall number
D-0259-2025
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.