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High risk Drugs & MedicationsClass II

BD ChloraPrep Hi-Lite Orange Recall

BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a) 100 x 10.5 mL appli

Updated June 11, 2026

BD ChloraPrep Hi-Lite Orange applicators (a skin antiseptic) were distributed without proper sterilization assurance. These products should have been sterilized before use but were sent directly to customers instead, creating a risk of infection.

Is the CareFusion 213, LLC recalled? Yes. This product was recalled by FDA on June 11, 2026. Details below.

What is recalled

BD ChloraPrep Hi-Lite Orange (2% chlorhexidine gluconate and 70% isopropyl alcohol) in 10.5 mL applicators: 100-count cases with NDC 54365-400-35 and Catalog Number 930715NS, or bulk Catalog Number 930715NSB. Manufactured by CareFusion 213, LLC in El Paso, TX.

Am I affected

You're affected if you have BD ChloraPrep Hi-Lite Orange 10.5 mL applicators (100-count cases) with NDC 54365-400-35, Catalog Number 930715NS, or bulk Catalog Number 930715NSB.

What to do right now

Stop using these applicators immediately. Contact your supplier or CareFusion 213, LLC (a subsidiary of Becton, Dickinson and Co.) for instructions on return or replacement of sterilized product.

The hazard

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

Brands affected

CareFusion 213, LLC
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0643-2026
Classification
Class II
Recalled
June 11, 2026
Read the official notice

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