Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

19 recalls · Class I, newest first

Class I · High risk

BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate

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.

Terminated Sterility / contamination CareFusion 213, LLC NDC 54365-400-33 D-0268-2021
Class I · High risk

BD ChloraPrep Clear

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.

Terminated Sterility / contamination CareFusion 213, LLC NDC 54365-400-32 D-0265-2021

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