The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0651-2026·Announced 2026-07-08

ChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Loss

CareFusion 213, LLC is recalling ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol applicators distributed nationwide because unsterilized units intended for further processing were distributed through the wrong channels.

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 a sterile pharmaceutical product distributed with lack of sterility assurance. The product is a topical antiseptic intended for medical use where sterility is critical to patient safety, meeting the Severe criteria.

Plain-English summary

CareFusion 213, LLC is recalling ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol), 500 x 1 mL applicators per case, NDC 54365-400-31, catalog number 930480NSB. The recall affects approximately 18,000 units distributed nationwide in the USA. Specific lot numbers affected include 4088933 (expiration 03/31/2027), 4177711, 4195438 (06/30/2027), 5051114 (02/29/2028), 5070540 (03/31/2028), 5106254 (04/30/2028), 5141607 (05/31/2028), and 5196494 (07/31/2028).

The recall was initiated because unsterilized ChloraPrep applicators intended for further processing and sterilization were distributed to customers outside of the intended distribution channel. These products lack assurance of sterility.

Customers who have received affected units should stop use and contact CareFusion 213, LLC for instructions on return or disposal of the product. Healthcare providers and patients should not use applicators from the affected lots.

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
18,000

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 (15)

  • Lot: 4088933
  • Exp 03/31/2027
  • 4177711
  • 4195438
  • Exp 06/30/2027
  • 5051114
  • Exp 02/29/2028
  • 5070540
  • Exp 03/31/2028
  • 5106254
  • Exp 04/30/2028
  • 5141607
  • Exp 05/31/2028
  • 5196494
  • Exp 07/31/2028.

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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Same brand · CHLORAPREP ONE-STEP

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Same hazard · lack of sterility

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