The Recall Desk
SevereFDA (Drugs)·D-0259-2025·Announced 2025-03-19

ChloraPrep One-Step Topical Drug Recalled for Fungal Contamination

CareFusion 213, LLC is recalling ChloraPrep One-Step, a preoperative skin preparation drug, due to non-sterility from a package lidding breach allowing fungal contamination. The recall affects 205,440 applicators distributed nationwide and in Canada.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall. Per the severity rubric, FDA Class I recalls are scored as Severe (minimum score 4). No illnesses or injuries are reported in the source material; contamination was detected through sterility testing.

Plain-English summary

CareFusion 213, LLC is recalling ChloraPrep One-Step (Chlorhexidine Gluconate and Isopropyl Alcohol), a sterile topical drug used for preoperative skin preparation. The recalled product consists of 1 mL applicators containing 2% chlorhexidine gluconate and 70% isopropyl alcohol, packaged as 60 applicators per carton. The recalled lot is Lot #3200240 with an expiration date of 6/30/2026.

The recall was issued due to a breach in the package lidding that allowed non-sterility contamination with Aspergillus penicillioides, a fungus. ChloraPrep One-Step is manufactured as a sterile product for topical use on unbroken skin prior to surgical procedures, and fungal contamination compromises product sterility.

The affected product was distributed nationwide and in Canada. Approximately 205,440 applicators are affected (NDC 54365-400-31), manufactured by CareFusion 213, LLC, a subsidiary of Becton, Dickinson and Co.

The FDA classifies this as a Class I recall. Consumers and healthcare facilities with this product should contact CareFusion 213, LLC or their distributor for return and disposal instructions.

The recalled product

Product
CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
Brand
CHLORAPREP ONE-STEP
Manufacturer
CareFusion 213, LLC
Category
Drug — Topical / Preoperative Preparation
Hazard
  • non-sterility
  • aspergillus

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 #: 3200240
  • Exp 6/30/2026

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · CHLORAPREP ONE-STEP

Same category