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

Amlodipine and 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 0378-1724-93 D-0323-2019
Class II · Moderate risk Ongoing

Amlodipine and 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 0378-1723-93 D-0322-2019
Class II · Moderate risk Ongoing

Amlodipine and 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 0378-1722-93 D-0321-2019
Class II · Moderate risk Ongoing

Amlodipine and 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 0378-1721-93 D-0320-2019
Class II · Moderate risk Ongoing

Amlodipine

Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Teva Pharmaceuticals USA NDC 0093-7809-56 D-0310-2019
Class II · Moderate risk Ongoing

Amlodipine

Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Teva Pharmaceuticals USA NDC 0093-7960-56 D-0309-2019
Class II · Moderate risk Ongoing

Amlodipine

Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Teva Pharmaceuticals USA NDC 0093-7810-56 D-0308-2019
Class II · Moderate risk Ongoing

Amlodipine

Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Teva Pharmaceuticals USA NDC 0093-7807-56 D-0307-2019
Class II · Moderate risk Ongoing

Amlodipine and Valsartan Tablets 10 mg/320 mg

Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Teva Pharmaceuticals USA NDC 0093-7693-56 D-0306-2019
Class II · Moderate risk Ongoing

Amlodipine and Valsartan Tablets 5 mg/320 mg

Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Teva Pharmaceuticals USA NDC 0093-7692-56 D-0305-2019
Class II · Moderate risk Ongoing

Amlodipine and Valsartan Tablets 10 mg/160 mg

Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Teva Pharmaceuticals USA NDC 0093-7961-56 D-0304-2019
Class II · Moderate risk Ongoing

Amlodipine and Valsartan Tablets 5 mg/160 mg

Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Teva Pharmaceuticals USA NDC 0093-7690-56 D-0303-2019
Class II · Moderate risk Ongoing

Amlodipine and Valsartan Tablets

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

Mylan Pharmaceuticals Inc. NDC 0378-1724-93 D-0318-2019
Class II · Moderate risk Ongoing

Valsartan and Hydrochlorothiazide Tablets

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

Mylan Pharmaceuticals Inc. NDC 0378-6325-05 D-0317-2019
Class II · Moderate risk Ongoing

Valsartan Tablets

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

Mylan Pharmaceuticals Inc. NDC 0378-5815-77 D-0316-2019
Class II · Moderate risk Ongoing

Valsartan Tablets

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

Mylan Pharmaceuticals Inc. NDC 0378-5807-93 D-0315-2019
Class II · Moderate risk Ongoing

Valsartan Tablets

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

Mylan Pharmaceuticals Inc. NDC 0378-5814-77 D-0314-2019
Class II · Moderate risk Ongoing

Valsartan Tablets

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

Mylan Pharmaceuticals Inc. NDC 0378-5813-77 D-0313-2019
Class II · Moderate risk Ongoing

Amlodipine and Valsartan Tablets

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

Mylan Pharmaceuticals Inc. NDC 0378-1722-93 D-0312-2019
Class II · Moderate risk Ongoing

Amlodipine and Valsartan Tablets

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

Mylan Pharmaceuticals Inc. NDC 0378-1721-93 D-0311-2019
Class II · Moderate risk Ongoing

Sandoz Losartan Potassium and Hydrochlorothiazide Tablets

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

Sandoz, Inc NDC 0781-5207-10 D-0359-2019
Class II · Moderate risk Ongoing

Amlodipine

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

Torrent Pharma Inc. D-1145-2018
Class II · Moderate risk Ongoing

Amlodipine

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

Torrent Pharma Inc. D-1144-2018
Class II · Moderate risk Ongoing

Amlodipine

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

Torrent Pharma Inc. D-1143-2018
Class II · Moderate risk Ongoing

Amlodipine

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

Torrent Pharma Inc. D-1142-2018