FDA Drug Recalls

559 recalls · Class II, newest first

Aug 17, 2018 Class II · Moderate risk

Amlodipine and Valsartan Tablets

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

Ongoing Nitrosamine impurity Torrent Pharma Inc. D-1138-2018

Aug 17, 2018 Class II · Moderate risk

Amlodipine and Valsartan Tablets

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

Ongoing Nitrosamine impurity Torrent Pharma Inc. D-1137-2018

Aug 17, 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-1136-2018

Aug 17, 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-1135-2018

Aug 17, 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

Aug 15, 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

Aug 14, 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

Aug 14, 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

Aug 14, 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

Aug 14, 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

Aug 10, 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

Aug 10, 2018 Class II · Moderate risk

Valsartan 160 mg Tablets

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

Terminated Nitrosamine impurity RemedyRepack Inc. D-1101-2018

Aug 10, 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

Aug 8, 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

Aug 8, 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

Aug 8, 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

Aug 8, 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

Jul 30, 2018 Class II · Moderate risk

Valsartan/HCTZ 320/25mg Tablets

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

Terminated Nitrosamine impurity NuCare Pharmaceuticals Inc NDC 68071-4183-3 D-1039-2018

Jul 30, 2018 Class II · Moderate risk

Valsartan/HCTZ 160/25mg Tablets

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

Terminated Nitrosamine impurity NuCare Pharmaceuticals Inc D-1038-2018

Jul 30, 2018 Class II · Moderate risk

Valsartan/HCTZ 160/12.5 mg Tablets

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

Terminated Nitrosamine impurity NuCare Pharmaceuticals Inc NDC 68071-4311-9 D-1037-2018

Jul 27, 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

Jul 27, 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

Jul 27, 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

Jul 26, 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

Jul 18, 2018 Class II · Moderate risk

AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle

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

Terminated Nitrosamine impurity Avkare Incorporated NDC 42291-888-90 D-1177-2018

Recalls by year

2026563
2025778
2024557
20231,122
20221,390
20211,152
2020930
20191,788
20181,681
20171,141
20161,199
20151,733
20141,309
20132,085
2012534
201134
20104
20072
20061