Independent register of U.S. FDA drug recalls · updated Oct 11, 2026
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FDA Drug Recalls

18,003 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

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

Indomethacin Capsules

Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.

Terminated Failed specification Hetero Labs, Ltd. - Unit III NDC 31722-543-01 D-1019-2018
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

Recalls by year