Class IIOngoing

BD ChloraPrep Clear recall

FDA recall D-0441-2025 · initiated May 15, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

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

Details

Product: 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.
Recalling company: CareFusion 213, LLC
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide in the U.S.
Initiated: May 15, 2025
FDA report date: May 28, 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-0441-2025 ↗

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