Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA drug recalls in 2018

Every FDA drug recall initiated in 2018, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.

1,681 recalls, newest first.

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
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

Recalls by year