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

1,463 recalls · Class I, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class I · High risk

Neostigmine Methylsulfate Injection Solution

Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL.

Terminated Labeling / mix-up Fagron Compounding Services LLC dba Fagron Sterile Services NDC 71266-2003-01 D-0911-2018
Class I · High risk

Neostigmine Methylsulfate Injection Solution

Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL.

Terminated Labeling / mix-up Fagron Compounding Services LLC dba Fagron Sterile Services NDC 71266-2003-02 D-0910-2018
Class I · High risk

Blissful Remedies

Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.

Terminated Microbial contamination World Organix, LLC D-1123-2018
Class I · High risk

Blissful Remedies Red Maeng Da

Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.

Terminated Microbial contamination World Organix, LLC D-1122-2018
Class I · High risk

Gaia Kratom

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

Terminated Microbial contamination Gaia Ethnobotanical LLC D-1016-2018
Class I · High risk

Gaia Kratom

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

Terminated Microbial contamination Gaia Ethnobotanical LLC D-1015-2018
Class I · High risk

Gaia Kratom

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

Terminated Microbial contamination Gaia Ethnobotanical LLC D-1014-2018
Class I · High risk

Gaia Kratom

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

Terminated Microbial contamination Gaia Ethnobotanical LLC D-1013-2018
Class I · High risk

Gaia Kratom

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

Terminated Microbial contamination Gaia Ethnobotanical LLC D-1012-2018
Class I · High risk

Gaia Kratom

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

Terminated Microbial contamination Gaia Ethnobotanical LLC D-1011-2018
Class I · High risk

Gaia Kratom

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

Terminated Microbial contamination Gaia Ethnobotanical LLC D-1010-2018
Class I · High risk

Gaia Kratom

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

Terminated Microbial contamination Gaia Ethnobotanical LLC D-1009-2018
Class I · High risk

Gaia Kratom

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

Terminated Microbial contamination Gaia Ethnobotanical LLC D-1008-2018
Class I · High risk

Gaia Kratom

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

Terminated Microbial contamination Gaia Ethnobotanical LLC D-1007-2018

Recalls by year