Class IOngoing

BD ChloraPrep FREPP Clear recall

FDA recall D-0625-2026 · initiated May 28, 2026

By the pharmaranks editorial teamReviewed against the FDA (openFDA) sourcesUpdated Jul 1, 2026How we research

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

Why it was recalled

Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.

Details

Product: BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30.
Recalling company: CareFusion 213, LLC
Classification: Class I
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide inthe USA, as well as other foreign distribution.
Initiated: May 28, 2026
FDA report date: Jul 1, 2026

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-0625-2026 ↗

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