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Torrent Pharma Recalls
84 recalls on record · August 7, 2013 to June 11, 2025 · Drugs
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 17, 2019DrugsFDA
Torrent Pharma Inc. recalls Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/12.5mg, a) 30-count (NDC: 13668-117-30), b) 90-count (NDC:
Hazard: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
April 17, 2019DrugsFDA
Torrent Pharma Inc. recalls Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b) 90-count (NDC: 1
Hazard: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
April 17, 2019DrugsFDA
Torrent Pharma Inc. recalls LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b) 1000-count (NDC: 13668-115-10), per bottle
Hazard: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
April 17, 2019DrugsFDA
Torrent Pharma Inc. recalls LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count (NDC: 13668-409-30), b) 90-count (NDC: 13668-409-90), c) 1000-count
Hazard: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
April 17, 2019DrugsFDA
Torrent Pharma Inc. recalls LOSARTAN POTASSIUM TABLETS, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b) 1000-count (NDC: 13668-113-10), per bottle,
Hazard: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
February 27, 2019DrugsFDA
Torrent Pharma Inc. recalls LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5 mg, a) 90-count bottle (NDC: 13668-116-90), b) 1000-
Hazard: 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.
February 27, 2019DrugsFDA
Torrent Pharma Inc. recalls LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP, 100 mg/12.5 mg, a) 90-count bottle (NDC: 13668-117-90), b) 100
Hazard: 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.
February 27, 2019DrugsFDA
Torrent Pharma Inc. recalls LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-113-90), Rx only, Manufactured by: Torrent Pharmaceu
Hazard: 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.
February 27, 2019DrugsFDA
Torrent Pharma Inc. recalls LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count bottle (NDC: 13668-409-30), b) 90-count bottle (NDC: 13668-409-90),
Hazard: 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.
February 27, 2019DrugsFDA
Torrent Pharma Inc. recalls LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 30-count (NDC: 13668-115-30), b) 90-count (NDC: 13668-115-90), c) 1000-count
Hazard: 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.
September 26, 2018DrugsFDA
Torrent Pharma Inc. recalls Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT P
Hazard: Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
September 5, 2018DrugsFDA
Torrent Pharma Inc. recalls Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactu
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
September 5, 2018DrugsFDA
Torrent Pharma Inc. recalls Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufact
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
September 5, 2018DrugsFDA
Torrent Pharma Inc. recalls Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufa
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
September 5, 2018DrugsFDA
Torrent Pharma Inc. recalls Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufa
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
September 5, 2018DrugsFDA
Torrent Pharma Inc. recalls Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 mg, 30 tablets per bottle, Rx Only, Manufact
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
September 5, 2018DrugsFDA
Torrent Pharma Inc. recalls Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceut
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
September 5, 2018DrugsFDA
Torrent Pharma Inc. recalls Amlodipine and Valsartan Tablets, USP, 10 mg/160mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceut
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
September 5, 2018DrugsFDA
Torrent Pharma Inc. recalls Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceut
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
September 5, 2018DrugsFDA
Torrent Pharma Inc. recalls Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceu
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
September 5, 2018DrugsFDA
Torrent Pharma Inc. recalls Valsartan Tablets USP, 320mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
September 5, 2018DrugsFDA
Torrent Pharma Inc. recalls Valsartan Tablets USP, 160mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
September 5, 2018DrugsFDA
Torrent Pharma Inc. recalls Valsartan Tablets USP, 80mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 7
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 7, 2013DrugsFDA
Torrent Pharma Inc recalls Olanzapine Tablets, USP, 10 mg, Rx Only, 30 tablets per bottle, Mfd for: Prasco Laboratories, Mason OH, 45040, USA, Mfd
Hazard: Defective Container; This action is being taken as a precautionary measure due to the product being re-packaged in the U.S. using a filler material that (removes or blocks) less moisture than what is approved in the application.