FDA Recall Database: Class I Recall: CHLORAPREP ONE-STEP by CareFusion 213, LLC

Key facts

What consumers should do

Consumers or facilities holding BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Applicators per inner Carton, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-31. from CareFusion 213, LLC should stop using the specific lot(s) named in the recall notice and follow the return or disposal instructions the firm provides. FDA recall records for drug and consumer products typically direct affected customers to contact the recalling firm or the distributor they purchased from to confirm whether their specific lot number is included, since recalls are usually lot-specific rather than a blanket recall of every unit of a product ever sold. Anyone experiencing an adverse reaction believed to be related to a recalled product is encouraged to contact their healthcare provider and to report it to FDA's MedWatch program. Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual lot status — contact the firm or your supplier directly.

What this classification means

A Class I recall is FDA's most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case — it reflects FDA's assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because Class I is reserved for the highest-risk defects, professionals and consumers handling an affected lot are generally advised to treat the recall as time-sensitive rather than routine.

CareFusion 213, LLC’s FDA history

Argus HQ has recorded 7 total FDA actions tied to CareFusion 213, LLC: 1 warning letter, 6 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Why was BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) an recalled?

FDA's recall record states the reason as: Non-Sterility: Due to presence of Aspergillus penicillioides.

Who should I contact about this recall?

Contact CareFusion 213, LLC directly, or the distributor/pharmacy that supplied the product, to confirm whether your specific lot or unit is affected. Argus HQ aggregates the public FDA recall record and is not the recalling firm.

Has CareFusion 213, LLC had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 7 total FDA actions tied to CareFusion 213, LLC, including 6 recalls and 1 warning letter.

What is the FDA recall number for this event?

FDA recall number D-0624-2026.

Related enforcement actions

• Warning letter: CareFusion 213, LLC — CGMP/Finished Pharmaceuticals/Adulterated (2026-04-30) →