ChloraPrep One-Step Recalled for Potential Fungal Growth and Sterility Breach
CareFusion 213, LLC is recalling ChloraPrep One-Step applicators due to potential fungal growth that may breach package integrity and compromise sterility.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
CareFusion 213, LLC is recalling approximately 24,969,700 cartons of CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL). The product is a sterile solution containing 2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol, packaged with 25 applicators per carton. The recall is classified as FDA Class II.
The recall was initiated because, at labeled storage conditions of 30°C and 75% relative humidity, there is a potential for the growth of Aspergillus penicillioides, a type of fungus. This growth could result in a breach of the package integrity, thereby compromising the assurance of sterility for the product.
The affected 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 the specific lot numbers and expiration dates listed in the official recall notice and discontinue use of any affected units.
The recalled product
- Product
- CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
- Brand
- CHLORAPREP ONE-STEP
- Manufacturer
- CareFusion 213, LLC
- Category
- Medical Device — Surgical Prep
- Affected units
- 24,969,700
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 (20)
- Lot and Exp Date: 0010759
- 11/30/2022
- 0025045
- 0035136
- 12/31/2022
- 0054691
- 2/28/2023
- 0057018
- 0058944
- 0062656
- 0063728
- 0063740
- 0064594
- 0065288
- 0066368
- 0067288
- 3/31/2023
- 0069106
- 0070865
- 0071359
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 for Lack of Sterile Assurance
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Antiseptic Applicators recalled for lack of sterility assurance
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Loss
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Antiseptic Applicators Distributed Without Sterilization
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 Applicators Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Topical Drug Recalled for Fungal Contamination
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- SevereChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance
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- SevereFDA Recalls Chloraprep One-Step Due to Potential Fungal Growth
FDA (Drugs) · 2021-03-03
- SevereChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Loss
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- SevereFDA Recalls Chloraprep One-Step Antiseptic Due to Non-Sterility Risk
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