Class IOngoing

BD ChloraPrep Clear 1mL Applicators recall

FDA recall D-0259-2025 · initiated Feb 14, 2025

Most serious — a reasonable probability that use will cause serious harm or death.

Why it was recalled

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

Details

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.
Recalling company: CareFusion 213, LLC
Classification: Class I
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide and Canada
Initiated: Feb 14, 2025
FDA report date: Mar 19, 2025

This recall is linked to a product we cover: Chloraprep with Tint →

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0259-2025 ↗

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