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

559 recalls · Class II, 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

Valsartan

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

Terminated Nitrosamine impurity Northwind Pharmaceuticals LLC D-1098-2018
Class II · Moderate risk

Valsartan

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

Terminated Nitrosamine impurity Northwind Pharmaceuticals LLC D-1097-2018
Class II · Moderate risk

Valsartan HCTZ

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

Terminated Nitrosamine impurity Northwind Pharmaceuticals LLC D-1096-2018
Class II · Moderate risk

Valsartan

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

Terminated Nitrosamine impurity Northwind Pharmaceuticals LLC D-1095-2018
Class II · Moderate risk

Unit Dose Valsartan Tablets

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

Terminated Nitrosamine impurity Major Pharmaceuticals NDC 0904-6594-61 D-0967-2018
Class II · Moderate risk

Unit Dose Valsartan Tablets

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

Terminated Nitrosamine impurity Major Pharmaceuticals NDC 0904-6594-61 D-0966-2018
Class II · Moderate risk

Valsartan Tablets

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

Ongoing Nitrosamine impurity A-S Medication Solutions LLC. NDC 54569-6582-0 D-1109-2018
Class II · Moderate risk

Valsartan Tablets

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

Ongoing Nitrosamine impurity A-S Medication Solutions LLC. NDC 54569-6583-0 D-1108-2018
Class II · Moderate risk

Valsartan Tablets

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

Ongoing Nitrosamine impurity Teva Pharmaceuticals USA NDC 0591-2170-19 D-0989-2018
Class II · Moderate risk

Valsartan Tablets

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

Ongoing Nitrosamine impurity Teva Pharmaceuticals USA NDC 0591-2169-19 D-0988-2018
Class II · Moderate risk

Valsartan Tablets

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

Ongoing Nitrosamine impurity Teva Pharmaceuticals USA NDC 0591-2168-19 D-0987-2018
Class II · Moderate risk

Valsartan Tablets

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

Ongoing Nitrosamine impurity Teva Pharmaceuticals USA NDC 0591-2167-30 D-0986-2018

Recalls by year