The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0625-2026·Announced 2026-07-01

ChloraPrep One-Step Antiseptic Solution Recall Due to Sterility Concerns

CareFusion is recalling 178,000 ChloraPrep One-Step antiseptic applicators (Lot #4073005) nationwide due to potential non-sterility from fungal contamination and seal breaches from paper lidding wrinkles.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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: The FDA classified this as a Class I recall, which per the rubric requires a minimum score of 4. Although no illnesses or injuries are reported in the source text, the non-sterility hazard in a topical antiseptic product used in medical settings meets the Severe threshold for FDA Class I classification.

Plain-English summary

CareFusion 213, LLC is recalling BD ChloraPrep FREPP Clear 1.5 mL applicators (2% chlorhexidine gluconate and 70% isopropyl alcohol) in packages of 20, NDC 54365-400-30, Lot #4073005 with expiration date 03/31/2027. Approximately 178,000 applicators have been distributed nationwide and internationally.

The recall was initiated due to two sterility-related defects. The product may not be sterile due to the presence of Aspergillus penicillioides (a fungus). Additionally, wrinkles in the paper lidding may compromise the seal area, resulting in a lack of assurance of sterility.

ChloraPrep One-Step is used as a topical antiseptic. Non-sterile products used in medical settings pose a risk of infection. Consumers, healthcare providers, and facilities should stop using the recalled applicators immediately. Any product from Lot #4073005 should not be used. Contact CareFusion or the FDA with questions.

The recalled product

Product
CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
Brand
CHLORAPREP ONE-STEP
Manufacturer
CareFusion 213, LLC
Category
Drug — Topical Antiseptic / Medical Device
Hazard
Affected units
178,000

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 (2)

  • Lot # 4073005
  • Exp 03/31/2027

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

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