ChloraPrep One-Step Recalled for Fungal Contamination and Package Breach
CareFusion 213, LLC is recalling ChloraPrep One-Step applicators because fungal growth breached package integrity. The product is a sterile skin antiseptic.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source metadata explicitly identifies this as an FDA Class I recall, which mandates a severity score of 5 per the rubric.
Plain-English summary
CareFusion 213, LLC is recalling 1,434,000 cartons of ChloraPrep One-Step (Chlorhexidine Gluconate and Isopropyl Alcohol) sterile solution applicators. The recall is due to a non-sterility issue where growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity at labeled storage conditions of 30°C/75% Relative Humidity.
The affected product is BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), sterile solution, 0.10 fl. oz. (3 ml) each, 25 applicators per carton. The specific lots and expiration dates affected are: 0107872 (4/30/2023), 0108556 (4/30/2023), 0148278 (4/30/2023), 0151978 (5/31/2023), 0155534 (5/31/2023), 0157085 (5/31/2023), 0160618 (5/31/2023), and 0167907 (5/31/2023).
The product was distributed nationwide in the USA and to Singapore, Chile, Oman, Columbia, United Arab Emirates, South Africa, Kuwait, Democratic Republic of the Congo, Qatar, Bahrain, Hong Kong, and Brazil. Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be stopped from use and returned to the supplier or disposed of according to local regulations, as the package integrity breach compromises the sterile status of the applicators.
The recalled product
- Product
- CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
- Brand
- CHLORAPREP ONE-STEP
- Manufacturer
- CareFusion 213, LLC
- Category
- Drug — Topical Antiseptic
- Affected units
- 1,434,000
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 (10)
- Lot and Exp Date: 0107872
- 4/30/2023
- 0108556
- 0148278
- 0151978
- 5/31/2023
- 0155534
- 0157085
- 0160618
- 0167907
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 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 8 products in this recall →Related recalls
Same brand · CHLORAPREP ONE-STEP
- SevereChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects
FDA (Drugs) · 2026-07-22
- SevereChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Loss
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Applicators Recalled for Lack of Sterile Assurance
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Antiseptic Applicators Distributed Without Sterilization
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Antiseptic Applicators recalled for lack of sterility assurance
FDA (Drugs) · 2026-07-08
Same manufacturer · CareFusion 213, LLC
See all →- SeverePurPrep Povidone Iodine and Isopropyl Alcohol Applicators Recall
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Sterile Solution Lacks Assurance of Sterility
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-08
Same hazard · fungal contamination
See all →- CriticalMedline Convenience Kits Recalled for Fungal Contamination Risk
FDA (Devices) · 2026-09-23
- CriticalMedline Convenience Kits Recalled for Potential Fungal Contamination
FDA (Devices) · 2026-09-23
- SevereMedline Convenience Kits Recalled for Fungal Contamination Risk
FDA (Devices) · 2026-09-23
- CriticalMedline Convenience Kits Recalled for Potential Fungal Contamination
FDA (Devices) · 2026-09-23
- CriticalMedline Recalls Blood and Urine Collection Kits Due to Fungal Contamination
FDA (Devices) · 2026-09-23
Similar recalls
- SevereChloraPrep One-Step Topical Antiseptic Recalled for Non-Sterility
FDA (Drugs) · 2026-07-01
- SevereChloraPrep One-Step Topical Drug Recalled for Fungal Contamination
FDA (Drugs) · 2025-03-19
- SevereChloraPrep One-Step Antiseptic Solution Recall Due to Sterility Concerns
FDA (Drugs) · 2026-07-01
- SevereChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Antiseptic Applicators recalled for lack of sterility assurance
FDA (Drugs) · 2026-07-08