US Drug Recall Register

FDA Drug Recalls

1,739 recalls · Class I, newest first

Class I · High risk Terminated

OPTIMUS LUBRICANTS Instant Hand Sanitizer

Reason Chemical Contamination: Products contain methanol and were below the label claim for ethanol content

Liq-E S.A. De C.V. D-0253-2021
Class I · High risk Terminated

blumen ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT

Reason Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.

4e Brands North America, Llc D-0031-2021
Class I · High risk Terminated

blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL

Reason Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.

4e Brands North America, Llc D-0029-2021
Class I · High risk Terminated

Daptomycin for Injection

Reason Presence of Particulate Matter

Mylan Institutional LLC NDC 67457-813-50 D-1484-2020
Class I · High risk Terminated

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

Reason 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.

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

ChloraPrep One-Step 2% w/v chlorhexidine gluconate

Reason 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.

CareFusion 213, LLC D-0267-2021
Class I · High risk Terminated

ChloraPrep With Tint 2% w/v chlorhexidine gluconate

Reason 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.

CareFusion 213, LLC D-0266-2021
Class I · High risk Terminated

BD ChloraPrep Clear

Reason 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.

CareFusion 213, LLC NDC 54365-400-32 D-0265-2021
Class I · High risk Terminated

Lemon Blossom Hand Sanitizer

Reason Microbial contamination of non-sterile products: positive microbial contamination in product.

Spartan Chemical Co Inc D-1503-2020
Class I · High risk Terminated

Mystic Shield PROTECTION

Reason Chemical Contamination: Presence of Undeclared Methanol

Transliquid Technologies, LLC D-1408-2020
Class I · High risk Terminated

Chlorhexidine Gluconate 0012 For Manufacturing

Reason Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches

Medichem S.A. NDC 53296-0012-0 D-1534-2020
Class I · High risk Terminated

All Clean Hand Sanitizer

Reason Chemical Contamination: Product contains undeclared methanol.

Itech 361 LLC D-1538-2020
Class I · High risk Terminated

ChlroraPrep One-Step

Reason Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides

CareFusion 213, LLC D-1511-2020
Class I · High risk Terminated

ChloraPrep With Tint

Reason Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides

CareFusion 213, LLC D-1510-2020
Class I · High risk Terminated

BD ChloraPrep Clear 3 mL Applicators

Reason Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides

CareFusion 213, LLC NDC 54365-400-32 D-1509-2020
Class I · High risk Terminated

Saniderm ADVANCED HAND SANITIZER

Reason Chemical Contamination: Product contains undeclared methanol.

Uvt INC D-1407-2020
Class I · High risk Completed

Herbzeedy

Reason Chemical contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1482-2020
Class I · High risk Completed

Goodness Gurus

Reason Chemical contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1481-2020
Class I · High risk Completed

Goodness Gurus

Reason Chemical contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1480-2020
Class I · High risk Completed

BC Hemp Co.

Reason Chemical contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1479-2020
Class I · High risk Completed

BC Hemp Co.

Reason Chemical contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1478-2020
Class I · High risk Completed

Tasty Drops

Reason Chemical contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1477-2020
Class I · High risk Completed

Tasty Drops

Reason Chemical contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1476-2020