BD ChloraPrep Hi-Lite Orange (CareFusion) – Non-Sterility Risk (2020)
Class I: 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
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.01 fl. oz. (3 ml) each, 25 Applicators in carton, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-33 REF 930415
Brand
CareFusion 213, LLC
Lot Codes / Batch Numbers
All lots including but not limited to the following lots distributed in Zone IV: Lot # 0107872, Exp. 04/30/2023, 0108556, Exp. 04/30/2023, 0148278, Exp. 04/30/2023, 0151978, Exp. 05/31/2023, 0155534, Exp. 05/31/2023, 0157085, Exp. 05/31/2023, 0160618, Exp. 05/31/2023, 0167907, Exp. 05/31/2023.
Products Sold
All lots including but not limited to the following lots distributed in Zone IV: Lot # 0107872, Exp. 04/30/2023; 0108556, Exp. 04/30/2023; 0148278, Exp. 04/30/2023; 0151978, Exp. 05/31/2023; 0155534, Exp. 05/31/2023; 0157085, Exp. 05/31/2023; 0160618, Exp. 05/31/2023; 0167907, Exp. 05/31/2023.
CareFusion 213, LLC is recalling BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA due to Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidit. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, PR
Page updated: Jan 7, 2026