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

40 recalls, 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 II · Moderate risk

Irbesartan and Hydrochlorothiazide Tablets

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Completed Nitrosamine impurity Prinston Pharmaceutical Inc NDC 43547-330-03 D-0413-2019
Class II · Moderate risk

Irbesartan and Hydrochlorothiazide Tablets

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Completed Nitrosamine impurity Prinston Pharmaceutical Inc NDC 43547-331-09 D-0412-2019
Class II · Moderate risk

Irbesartan and Hydrochlorothiazide Tablets

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Completed Nitrosamine impurity Prinston Pharmaceutical Inc NDC 43547-331-03 D-0411-2019
Class II · Moderate risk

Irbesartan and HydrochlorothiazideTablets

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Completed Nitrosamine impurity Prinston Pharmaceutical Inc NDC 43547-330-09 D-0410-2019
Class II · Moderate risk

Irbesartan Tablets 300 mg 90 count Rx only Manufactured by…

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Completed Nitrosamine impurity Prinston Pharmaceutical Inc NDC 43547-376-09 D-0409-2019
Class II · Moderate risk

Camber Pharmaceuticals

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Completed Nitrosamine impurity Hetero Labs Limited Unit V NDC 31722-748-90 D-1116-2018
Class II · Moderate risk

Camber Pharmaceuticals

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Completed Nitrosamine impurity Hetero Labs Limited Unit V NDC 31722-747-90 D-1115-2018
Class II · Moderate risk

Camber Pharmaceuticals

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Completed Nitrosamine impurity Hetero Labs Limited Unit V NDC 31722-746-90 D-1114-2018
Class II · Moderate risk

Camber Pharmaceuticals

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Completed Nitrosamine impurity Hetero Labs Limited Unit V NDC 31722-745-30 D-1113-2018

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