ChloraPrep One-Step Topical Applicators Recalled for Unsupported Shelf-Life Claims
BD ChloraPrep One-Step topical applicators are recalled because the 36-month shelf life is not supported by stability data; the product may develop fungal contamination beyond 12 months.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II precautionary recall based on stability data showing potential fungal growth only under specific improper storage conditions, with no reported illnesses or confirmed contamination. The labeling error (36-month expiry unsupported) constitutes a minor compliance issue.
Plain-English summary
BD ChloraPrep One-Step (2% chlorhexidine gluconate and 70% isopropyl alcohol) sterile topical applicators are being recalled. The product is supplied in 0.03 mL/1 mL single-use pouches, with 60 applicators per carton. This recall affects 398,160 cartons that were distributed nationwide to 100 consignees.
The manufacturer, CareFusion 213, LLC, initiated this precautionary recall because stability testing shows that the labeled 36-month shelf life is not substantiated. Stability studies indicate that if the affected lots are stored at 30°C and 75% relative humidity continuously beyond 12 months, they may develop growth of Aspergillus penicillioides, a fungal contaminant.
The affected lots are #2272350 and #2301939, both with expiration dates of 09/30/2025. Healthcare facilities and distributors with these lots should remove the affected products from use. Customers should refer to the full recall notice for handling instructions and to verify whether their inventory includes the affected lot numbers.
The recalled product
- Product
- CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
- Brand
- CHLORAPREP ONE-STEP
- Manufacturer
- CareFusion 213, LLC
- Category
- Drug — Surgical Preparation
- Affected units
- 398,160
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 (3)
- Lot # 2272350
- Exp. Date 09/30/2025 and Lot # 2301939
- Exp. Date 09/30/2025
Distribution
Distributed nationwide across the United States.
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 Applicators Recalled for Lack of Sterility Assurance
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
Similar recalls
- CriticalChloraPrep One-Step Recalled for Fungal Contamination and Package Breach
FDA (Drugs) · 2021-05-05
- SevereChloraPrep One-Step Recalled for Potential Fungal Growth and Package Breach
FDA (Drugs) · 2021-05-05
- HighChloraPrep One-Step Recalled for Potential Fungal Growth and Sterility Breach
FDA (Drugs) · 2021-05-05
- SevereChloraPrep One-Step Topical Antiseptic Recalled for Non-Sterility
FDA (Drugs) · 2026-07-01
- SevereChloraPrep One-Step Antiseptic Solution Recall Due to Sterility Concerns
FDA (Drugs) · 2026-07-01
- CriticalFDA Recalls Chloraprep One-Step Applicators Due to Non-Sterility
FDA (Drugs) · 2020-08-26