US Drug Recall Register

FDA Drug Recalls

2,661 recalls, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 2026202520242023
Class II · Moderate risk Ongoing

Valsartan Tablets USP 320 mg

Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Aurobindo Pharma USA Inc. NDC 65862-573-90 D-1035-2019
Class II · Moderate risk Ongoing

Valsartan tablets USP 320 mg

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Aurobindo Pharma USA Inc. NDC 65862-573-90 D-0370-2019
Class II · Moderate risk Ongoing

Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Aurobindo Pharma USA Inc. NDC 65862-549-90 D-0369-2019
Class II · Moderate risk Ongoing

Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Aurobindo Pharma USA Inc. NDC 65862-547-90 D-0368-2019
Class II · Moderate risk Ongoing

Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Aurobindo Pharma USA Inc. NDC 65862-551-90 D-0367-2019
Class II · Moderate risk Ongoing

Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Aurobindo Pharma USA Inc. NDC 65862-548-90 D-0366-2019
Class II · Moderate risk Ongoing

Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Aurobindo Pharma USA Inc. NDC 65862-550-90 D-0365-2019
Class II · Moderate risk Ongoing

Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Aurobindo Pharma USA Inc. NDC 65862-740-30 D-0364-2019
Class II · Moderate risk Ongoing

Amlodipine and Valsartan Tablets USP 5 mg/320 mg

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Aurobindo Pharma USA Inc. NDC 65862-738-30 D-0363-2019
Class II · Moderate risk Ongoing

Amlodipine and Valsartan Tablets USP 10 mg/160 mg

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Aurobindo Pharma USA Inc. NDC 65862-739-30 D-0362-2019
Class II · Moderate risk Ongoing

Amlodipine and Valsartan Tablets USP 5 mg/160 mg

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Aurobindo Pharma USA Inc. NDC 65862-737-30 D-0361-2019
Class II · Moderate risk Ongoing

LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Torrent Pharma Inc. D-0505-2019
Class II · Moderate risk Ongoing

LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Torrent Pharma Inc. D-0504-2019
Class II · Moderate risk Ongoing

Losartan Potassium Tablets

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Torrent Pharma Inc. D-0503-2019
Class II · Moderate risk Ongoing

Losartan Potassium Tablets

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Torrent Pharma Inc. D-0502-2019
Class II · Moderate risk Ongoing

Losartan Potassium Tablets

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Torrent Pharma Inc. D-0501-2019
Class II · Moderate risk Ongoing

Valsartan and Hydrochlorothiazide Tablets

Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Mylan Laboratories Limited, (Nashik FDF) NDC 0378-6325-77 D-0332-2019
Class II · Moderate risk Ongoing

Valsartan and Hydrochlorothiazide Tablets

Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Mylan Laboratories Limited, (Nashik FDF) NDC 0378-6324-77 D-0331-2019
Class II · Moderate risk Ongoing

Valsartan and Hydrochlorothiazide Tablets

Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Mylan Laboratories Limited, (Nashik FDF) NDC 0378-6323-77 D-0330-2019
Class II · Moderate risk Ongoing

Valsartan and Hydrochlorothiazide Tablets

Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Mylan Laboratories Limited, (Nashik FDF) NDC 0378-6322-77 D-0329-2019
Class II · Moderate risk Ongoing

Valsartan and Hydrochlorothiazide Tablets

Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Mylan Laboratories Limited, (Nashik FDF) NDC 0378-6321-77 D-0328-2019
Class II · Moderate risk Ongoing

Valsartan Tablets

Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Mylan Laboratories Limited, (Nashik FDF) NDC 0378-5815-77 D-0327-2019
Class II · Moderate risk Ongoing

Valsartan Tablets

Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Mylan Laboratories Limited, (Nashik FDF) NDC 0378-5814-77 D-0326-2019
Class II · Moderate risk Ongoing

Valsartan Tablets

Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Mylan Laboratories Limited, (Nashik FDF) NDC 0378-5813-77 D-0325-2019
Class II · Moderate risk Ongoing

Valsartan Tablets

Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Mylan Laboratories Limited, (Nashik FDF) NDC 0378-5807-93 D-0324-2019