Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Chlorhexidine recalled?

Yes — there is an active recall. 19 ongoing FDA recalls mention Chlorhexidine (86 total). Check the affected lots below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Chlorhexidine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Chlorhexidine recalls on record

none so far in 2026; 86 on record, newest first
Class II · Moderate risk

ChloraPrep One-Step 2% w/v chlorhexidine gluconate

CGMP Deviations: 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.

Terminated Labeling / mix-up CareFusion 213, LLC D-0349-2021
Class II · Moderate risk

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

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.

Terminated Sterility / contamination CareFusion 213, LLC NDC 54365-400-33 D-0348-2021
Class II · Moderate risk

BD ChloraPrep Clear

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.

Terminated Sterility / contamination CareFusion 213, LLC NDC 54365-400-32 D-0347-2021
Class I · High risk

ChloraPrep With Tint 2% w/v chlorhexidine gluconate

Microbial Contamination of Non-Sterile Product:.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.

Terminated Microbial contamination CareFusion 213, LLC D-0346-2021
Class I · High risk

ChloraPrep One-Step 2% w/v chlorhexidine gluconate

Microbial Contamination of Non-Sterile Product.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.

Terminated Microbial contamination CareFusion 213, LLC D-0345-2021
Class I · High risk

BD ChloraPrep Clear

Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.

Terminated Sterility / contamination CareFusion 213, LLC NDC 54365-400-32 D-0343-2021
Class II · Moderate risk

Paroex (Chlorhexidine Gluconate)

cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions

Ongoing Microbial contamination Sunstar Americas, Inc. NDC 52376-021-02 D-0222-2021
Class I · High risk

Chlorhexidine Gluconate Oral Rinse USP

Microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer because it was contaminated with the bacteria Burkholderia lata.

Terminated Microbial contamination Lohxa LLC NDC 70166-027-15 D-0111-2021
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

ChloraPrep One-Step 2% w/v chlorhexidine gluconate

Microbial Contamination of Non-Sterile Product: 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 Microbial contamination CareFusion 213, LLC D-0267-2021
Class I · High risk

ChloraPrep With Tint 2% w/v chlorhexidine gluconate

Microbial Contamination of Non-Sterile Products: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 Microbial contamination CareFusion 213, LLC D-0266-2021
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
Class II · Moderate risk

Antibacterial Hand Soap

CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

Terminated cGMP deviation Inopak Ltd D-1315-2019
Class II · Moderate risk

Chlorhexidine 0.12% liquid

Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).

Terminated Labeling / mix-up Prescript Pharmaceuticals, Inc. D-0807-2018