US Drug Recall Register

FDA Drug Recalls

17,898 recalls, newest first

Class I · High risk Terminated

Dr. King's Lymph Detox

Reason Microbial contamination

King Bio Inc. NDC 57955-5063-2 D-0522-2019
Class II · Moderate risk Terminated

Valsartan

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

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

Valsartan

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

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

Valsartan HCTZ

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

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

Valsartan

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

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

Indomethacin Capsules

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

Hetero Labs, Ltd. - Unit III NDC 31722-543-01 D-1019-2018
Class II · Moderate risk Terminated

Potassium Citrate Extended-Release Tablets

Reason Failed Tablet/Capsule Specifications: Tablet breakage

Vensun Pharmaceuticals INC NDC 42543-407-01 D-1018-2018
Class II · Moderate risk Terminated

Potassium Citrate Extended-Release Tablets

Reason Failed Tablet/Capsule Specifications: Tablet breakage

Vensun Pharmaceuticals INC NDC 42543-408-01 D-1017-2018
Class II · Moderate risk Terminated

Unit Dose Valsartan Tablets

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

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

Unit Dose Valsartan Tablets

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

Major Pharmaceuticals NDC 0904-6594-61 D-0966-2018
Class II · Moderate risk Ongoing

Valsartan and Hydrochlorothiazide Tablets

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

A-S Medication Solutions LLC. D-1111-2018
Class II · Moderate risk Ongoing

Valsartan and Hydrochlorothiazide Tablets

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

A-S Medication Solutions LLC. D-1110-2018
Class II · Moderate risk Ongoing

Valsartan Tablets

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

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

Valsartan Tablets

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

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

Eyewash Purified water 98.3%

Reason CGMP Deviations

Longbow First Aid Products Manufactory NDC 6910-3218-07 D-1049-2018