FDA Recall D-0259-2025

CareFusion 213, LLC · El Paso, TX

Class I — life-threatening Ongoing 454 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

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.

Lot / code: Lot #: 3200240, Exp 6/30/2026

Quantity: 205,440 applicators

Reason for recall

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

Recall record

Recall number: D-0259-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution: Nationwide and Canada
Recall initiated: 2025-02-14
Classified by FDA Center: 2025-03-07
FDA published: 2025-03-19
Recalling firm: CareFusion 213, LLC
Firm location: El Paso, TX

Drug identification

Brand name(s): CHLORAPREP ONE-STEP
Generic name(s): CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL
Manufacturer(s): CareFusion 213, LLC
NDC(s): 54365-400
Route(s): TOPICAL

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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