Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Ongoing drug recalls - open right now

Every FDA drug recall whose status is still Ongoing: the firm is still removing product from the market, or the FDA has not yet closed the file. Some were opened years ago and never formally terminated, so check the initiation date as well as the status.

2,760 recalls, newest first.

Class II · Moderate risk

Valsartan tablets USP 320 mg

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.

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

Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg

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.

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

Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg

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.

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

Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg

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.

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

Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg

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.

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

Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg

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.

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

Amlodipine and Valsartan Tablets USP 5 mg/320 mg

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.

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

Amlodipine and Valsartan Tablets USP 10 mg/160 mg

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.

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

Amlodipine and Valsartan Tablets USP 5 mg/160 mg

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.

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

LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS

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.

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

LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS

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.

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

Losartan Potassium Tablets

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.

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

Losartan Potassium Tablets

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.

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

Losartan Potassium Tablets

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.

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

Valsartan and Hydrochlorothiazide Tablets

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

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

Valsartan and Hydrochlorothiazide Tablets

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

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

Valsartan and Hydrochlorothiazide Tablets

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

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

Valsartan and Hydrochlorothiazide Tablets

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

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

Valsartan and Hydrochlorothiazide Tablets

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

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

Valsartan Tablets

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

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

Valsartan Tablets

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

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

Valsartan Tablets

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

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

Valsartan Tablets

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

Ongoing Nitrosamine impurity Mylan Laboratories Limited, (Nashik FDF) NDC 0378-5807-93 D-0324-2019
Class II · Moderate risk

Amlodipine and Valsartan Tablets

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

Ongoing Nitrosamine impurity Mylan Laboratories Limited, (Nashik FDF) NDC 0378-1724-93 D-0323-2019

Recalls by year