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

131 recalls, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2018 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class II · Moderate risk

Valsartan Tablets USP

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

Ongoing Nitrosamine impurity Torrent Pharma Inc. D-1135-2018
Class II · Moderate risk

Valsartan Tablets USP

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

Ongoing Nitrosamine impurity Torrent Pharma Inc. D-1134-2018
Class II · Moderate risk

Valsartan Tablets USP 320 mg

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

Terminated Nitrosamine impurity Preferred Pharmaceuticals, Inc NDC 68788-6882-9 D-1107-2018
Class II · Moderate risk

Valsartan Tablets

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

Terminated Nitrosamine impurity AVKARE Inc. NDC 50268-786-13 D-1133-2018
Class II · Moderate risk

Valsartan Tablets

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

Terminated Nitrosamine impurity AVKARE Inc. NDC 50268-785-15 D-1132-2018
Class II · Moderate risk

Valsartan Tablets

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

Terminated Nitrosamine impurity AVKARE Inc. NDC 50268-784-15 D-1131-2018
Class II · Moderate risk

Valsartan Tablets

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

Terminated Nitrosamine impurity AVKARE Inc. NDC 50268-783-15 D-1130-2018
Class II · Moderate risk

Valsartan 320 mg Tablets

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

Terminated Nitrosamine impurity RemedyRepack Inc. NDC 61786-0793-19 D-1102-2018
Class II · Moderate risk

Valsartan 80 mg Tablet

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

Terminated Nitrosamine impurity RemedyRepack Inc. NDC 61786-0791-19 D-1100-2018
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 31722-748-90 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
Class II · Moderate risk

Valsartan 320 mg tablets

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

Terminated Nitrosamine impurity Bryant Ranch Prepack Inc. NDC 71335-0567-2 D-1029-2018
Class II · Moderate risk

Valsartan 320 mg tablets

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

Terminated Nitrosamine impurity Bryant Ranch Prepack Inc. NDC 63629-6905-1 D-1028-2018
Class II · Moderate risk

Valsartan 80 mg tablets

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

Terminated Nitrosamine impurity Bryant Ranch Prepack Inc. NDC 63629-6922-2 D-1027-2018
Class II · Moderate risk

Valsartan tablets 160 mg

Carcinogen impurity detected in API used to manufacture drug product.

Terminated Nitrosamine impurity H J Harkins Company Inc dba Pharma Pac NDC 43547-0369-09 D-1022-2018

Recalls by year