BD ChloraPrep Hi-Lite Orange (CareFusion) – Sterility Risk (2021)
Class II: 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
Class II recall indicates potential for temporary health effects.
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, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is intact. 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
Lot and Exp Date: 0018578, 11/30/2022, 0058277, 2/28/2023, 0059141, 2/28/2023, 0066365, 2/28/2023, 0067289, 3/31/2023, 0070866, 3/31/2023, 0074038, 3/31/2023, 0076034, 3/31/2023, 0084619, 3/31/2023, 0086158, 3/31/2023, 0090894, 3/31/2023, 0093903, 3/31/2023, 0095838, 3/31/2023, 0097561, 3/31/2023, 0098470, 3/31/2023, 0100383, 2/28/2023, 0109632, 4/30/2023, 0111185, 4/30/2023, 0113339, 4/30/2023, 0115853, 4/30/2023, 0121982, 4/30/2023, 0122192, 4/30/2023, 0122193, 4/30/2023, 0122194, 4/30/2023, 0128821, 4/30/2023, 0129409, 4/30/2023, 0135287, 4/30/2023, 0157083, 5/31/2023, 0161219, 5/31/2023, 0164032, 6/30/2023, 0164595, 5/31/2023, 0168228, 6/30/2023, 0177338, 6/30/2023, 0177384, 6/30/2023, 0178587, 6/30/2023, 0198836, 7/31/2023, 0199909, 6/30/2023, 0204887, 7/31/2023, 0205674, 6/30/2023, 0206366, 7/31/2023, 0207651, 7/31/2023, 0210578, 7/31/2023, 0227493, 7/31/2023, 0241043, 8/31/2023, 0249695, 8/31/2023, 0252883, 8/31/2023, 0254864, 8/31/2023, 0255091, 8/31/2023, 0259156, 9/30/2023, 0263754, 9/30/2023, 0267575, 9/30/2023, 0272405, 9/30/2023, 0300187, 10/31/2023, 0304315, 10/31/2023, 0305488, 10/31/2023, 0306841, 10/31/2023, 0307140, 9/30/2023, 0312694, 10/31/2023, 0313824, 10/31/2023, 0319649, 11/30/2023, 0324409, 11/30/2023, 0325577, 11/30/2023, 0326746, 11/30/2023, 0330938, 11/30/2023, 0335971, 11/30/2023, 0340937, 11/30/2023, 0347570, 12/31/2023, 0347571, 12/31/2023, 0355671, 12/31/2023, 0356362, 12/31/2023, 1008758, 12/31/2023, 1009747, 12/31/2023, 1028187, 1/31/2024, 1033578, 1/31/2024, 1034948, 1/31/2024, 1035662, 1/31/2024, 1036544, 1/31/2024, 1055547, 2/29/2024, 1060432, 2/29/2024, 9324226, 10/31/2022, 9343836, 11/30/2022, 9344810, 10/31/2022
Products Sold
Lot and Exp Date: 0018578, 11/30/2022; 0058277, 2/28/2023; 0059141, 2/28/2023; 0066365, 2/28/2023; 0067289, 3/31/2023; 0070866, 3/31/2023; 0074038, 3/31/2023; 0076034, 3/31/2023; 0084619, 3/31/2023; 0086158, 3/31/2023; 0090894, 3/31/2023; 0093903, 3/31/2023; 0095838, 3/31/2023; 0097561, 3/31/2023; 0098470, 3/31/2023; 0100383, 2/28/2023; 0109632, 4/30/2023; 0111185, 4/30/2023; 0113339, 4/30/2023; 0115853, 4/30/2023; 0121982, 4/30/2023; 0122192, 4/30/2023; 0122193, 4/30/2023; 0122194, 4/30/2023; 0128821, 4/30/2023; 0129409, 4/30/2023; 0135287, 4/30/2023; 0157083, 5/31/2023; 0161219, 5/31/2023; 0164032, 6/30/2023; 0164595, 5/31/2023; 0168228, 6/30/2023; 0177338, 6/30/2023; 0177384, 6/30/2023; 0178587, 6/30/2023; 0198836, 7/31/2023; 0199909, 6/30/2023; 0204887, 7/31/2023; 0205674, 6/30/2023; 0206366, 7/31/2023; 0207651, 7/31/2023; 0210578, 7/31/2023; 0227493, 7/31/2023; 0241043, 8/31/2023; 0249695, 8/31/2023; 0252883, 8/31/2023; 0254864, 8/31/2023; 0255091, 8/31/2023; 0259156, 9/30/2023; 0263754, 9/30/2023; 0267575, 9/30/2023; 0272405, 9/30/2023; 0300187, 10/31/2023; 0304315, 10/31/2023; 0305488, 10/31/2023; 0306841, 10/31/2023; 0307140, 9/30/2023; 0312694, 10/31/2023; 0313824, 10/31/2023; 0319649, 11/30/2023; 0324409, 11/30/2023; 0325577, 11/30/2023; 0326746, 11/30/2023; 0330938, 11/30/2023; 0335971, 11/30/2023; 0340937, 11/30/2023; 0347570, 12/31/2023; 0347571, 12/31/2023; 0355671, 12/31/2023; 0356362, 12/31/2023; 1008758, 12/31/2023; 1009747, 12/31/2023; 1028187, 1/31/2024; 1033578, 1/31/2024; 1034948, 1/31/2024; 1035662, 1/31/2024; 1036544, 1/31/2024; 1055547, 2/29/2024; 1060432, 2/29/2024; 9324226, 10/31/2022; 9343836, 11/30/2022; 9344810, 10/31/2022;
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 Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential. 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
Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, 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 noticePage updated: Jan 7, 2026