The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0650-2026·Announced 2026-07-08

ChloraPrep One-Step Sterile Solution Lacks Assurance of Sterility

CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) applicators distributed nationwide. The products were unsterilized and distributed outside the intended channel intended for further processing and sterilization.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall involving lack of sterility assurance for a topical drug product intended for medical use. The distribution of unsterilized applicators intended for sterilization represents a significant breach of product integrity and safety controls, meeting the Severe threshold for Class II recalls.

Plain-English summary

CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol), a topical drug product supplied as sterile applicators. The recall affects BD ChloraPrep Scrub Teal applicators packaged as 25 x 26 mL applicators per case (NDC 54365-400-39, catalog number 930825NS, Lot 3352149, Exp 12/31/2026) and 50 x 26 mL applicators per case (NDC 54365-400-39, catalog number 930825NSB, Lots 5028798 Exp 01/31/2028 and 5069651 Exp 03/31/2028). The products were intended for further processing and sterilization but were instead distributed to customers outside of the intended distribution channel, creating a lack of assurance of sterility.

The recalled applicators were distributed nationwide in the USA. Customers who have received these products should contact CareFusion 213, LLC or their healthcare provider for guidance on appropriate handling and replacement supplies.

The recalled product

Product
CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
Brand
CHLORAPREP ONE-STEP
Manufacturer
CareFusion 213, LLC
Category
Drug — Topical / Antiseptic
Hazard
Affected units
125

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Lot: a) 3352149
  • Exp 12/31/2026 b) 5028798
  • Exp 01/31/2028
  • 5069651
  • Exp 03/31/2028.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 10 recalled by CareFusion 213, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

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