CHLORAPREP ONE-STEP
Recalling Firm / Manufacturer: CareFusion 213, LLC
(El Paso, TX, United States)
FDA Recall Number: D-0441-2025
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
CHLORAPREP ONE-STEP
Generic Name
CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL
Active Substance(s)
Chlorhexidine Gluconate, Isopropyl Alcohol
Administration Route
Topical
National Drug Code (NDC)
54365-400
Total Quantity Recalled
385,200 applicators
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Full Product Description
Packaging specifications and labeling details
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.
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
May 28, 2025
Firm Initiation Date
May 15, 2025
FDA Classification Date
May 20, 2025
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot #s: 3354127 and 3350974, Exp Date: 12/31/2026
Distribution Information
Geographic scope of affected shipments
Nationwide in the U.S.
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0441-2025
Questo Retrieval Date: July 31, 2026 14:36 1785508616UTCC