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FDA Drug Recalls

2,661 recalls, newest first

Class II · Moderate risk Ongoing Dec 31, 2018

Valsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC…

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

Aurobindo Pharma USA Inc. NDC 65862-573-90 D-1035-2019

Class II · Moderate risk Ongoing Dec 31, 2018

Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC…

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

Aurobindo Pharma USA Inc. NDC 65862-573-90 D-0370-2019

Class II · Moderate risk Ongoing Dec 31, 2018

Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA…

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

Aurobindo Pharma USA Inc. NDC 65862-549-90 D-0369-2019

Class II · Moderate risk Ongoing Dec 31, 2018

Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA…

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

Aurobindo Pharma USA Inc. NDC 65862-547-90 D-0368-2019

Class II · Moderate risk Ongoing Dec 31, 2018

Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA…

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

Aurobindo Pharma USA Inc. NDC 65862-551-90 D-0367-2019

Class II · Moderate risk Ongoing Dec 31, 2018

Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA…

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

Aurobindo Pharma USA Inc. NDC 65862-548-90 D-0366-2019

Class II · Moderate risk Ongoing Dec 31, 2018

Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA…

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

Aurobindo Pharma USA Inc. NDC 65862-550-90 D-0365-2019

Class II · Moderate risk Ongoing Dec 31, 2018

Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc…

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

Aurobindo Pharma USA Inc. NDC 65862-740-30 D-0364-2019

Class II · Moderate risk Ongoing Dec 31, 2018

Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc…

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

Aurobindo Pharma USA Inc. NDC 65862-738-30 D-0363-2019

Class II · Moderate risk Ongoing Dec 31, 2018

Amlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc…

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

Aurobindo Pharma USA Inc. NDC 65862-739-30 D-0362-2019

Class II · Moderate risk Ongoing Dec 31, 2018

Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc…

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

Aurobindo Pharma USA Inc. NDC 65862-737-30 D-0361-2019

Class II · Moderate risk Ongoing Dec 20, 2018

LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5 mg, a) 90-count bottle (NDC: 13668-116-90), b) 1000-count…

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

Torrent Pharma Inc. D-0505-2019

Class II · Moderate risk Ongoing Dec 20, 2018

LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP, 100 mg/12.5 mg, a) 90-count bottle (NDC: 13668-117-90), b) 1000-count…

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

Torrent Pharma Inc. D-0504-2019

Class II · Moderate risk Ongoing Dec 20, 2018

LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-113-90), Rx only, Manufactured by: Torrent Pharmaceuticals…

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

Torrent Pharma Inc. D-0503-2019

Class II · Moderate risk Ongoing Dec 20, 2018

LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count bottle (NDC: 13668-409-30), b) 90-count bottle (NDC: 13668-409-90), c)…

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

Torrent Pharma Inc. D-0502-2019

Class II · Moderate risk Ongoing Dec 20, 2018

LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 30-count (NDC: 13668-115-30), b) 90-count (NDC: 13668-115-90), c) 1000-count (NDC…

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

Torrent Pharma Inc. D-0501-2019

Class II · Moderate risk Ongoing Dec 4, 2018

Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (NDC 0378-6325-77), (b) 500-count bottles (NDC…

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

Mylan Laboratories Limited, (Nashik FDF) NDC 0378-6325-77 D-0332-2019

Class II · Moderate risk Ongoing Dec 4, 2018

Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg, (a) 90-count bottle (NDC 0378-6324-77), (b) 500-count bottles (NDC…

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

Mylan Laboratories Limited, (Nashik FDF) NDC 0378-6324-77 D-0331-2019

Class II · Moderate risk Ongoing Dec 4, 2018

Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle (NDC 0378-6323-77), (b) 500-count bottles (NDC…

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

Mylan Laboratories Limited, (Nashik FDF) NDC 0378-6323-77 D-0330-2019

Class II · Moderate risk Ongoing Dec 4, 2018

Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle (NDC 0378-6322-77), (b) 500-count bottles (NDC…

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

Mylan Laboratories Limited, (Nashik FDF) NDC 0378-6322-77 D-0329-2019

Class II · Moderate risk Ongoing Dec 4, 2018

Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottle (NDC 0378-6321-77), (b) 500-count bottles (NDC…

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

Mylan Laboratories Limited, (Nashik FDF) NDC 0378-6321-77 D-0328-2019

Class II · Moderate risk Ongoing Dec 4, 2018

Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc…

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

Mylan Laboratories Limited, (Nashik FDF) NDC 0378-5815-77 D-0327-2019

Class II · Moderate risk Ongoing Dec 4, 2018

Valsartan Tablets, USP 160 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc…

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

Mylan Laboratories Limited, (Nashik FDF) NDC 0378-5814-77 D-0326-2019

Class II · Moderate risk Ongoing Dec 4, 2018

Valsartan Tablets, USP 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc…

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

Mylan Laboratories Limited, (Nashik FDF) NDC 0378-5813-77 D-0325-2019

Class II · Moderate risk Ongoing Dec 4, 2018

Valsartan Tablets, USP 40 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc…

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

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