Torrent Pharma recalls

Torrent Pharma appears in 84 official U.S. recall notices indexed by RecallRadar.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• Diphenhist Oral Solution (Diphenhydramine HCl, USP), 12.5 mg/5 mL, a) 4 FL. oz. (118 mL) bottle, NDC: 0536-0770-97, b) One Pint (473 mL) bo…
  FDA Drug · Class II · 2019-06-19 · Torrent Pharma
  Reason: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
• Hyoscyamine Oral Drops 0.125 mg/mL, Rx Only, 15 mL bottle (0.5 FL. oz.), NDC: 39328-047-15, Manuf. for Patrin Pharma, Skokie IL 60076
  FDA Drug · Class II · 2019-06-19 · Torrent Pharma
  Reason: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
• Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL, For Oral Use Only, Rx Only, 120 mL bottle, NDC 23155-292-51, Mfd for Heritage Pharmace…
  FDA Drug · Class II · 2019-06-19 · Torrent Pharma
  Reason: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
• Losartan Potassium and Hydrochlorothiazide Tablets, USP, 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b) 90-count (NDC: 13668-116-90), c)…
  FDA Drug · Class II · 2019-05-08 · Torrent Pharma
  Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
• Losartan Potassium Tablets, USP, 50 mg, a) 90-count (NDC: 13668-409-90), b)1000-count (NDC: 13668-409-10) per bottle, Rx only, Manufactured…
  FDA Drug · Class II · 2019-05-08 · Torrent Pharma
  Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
• Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/12.5mg, a) 90-count (NDC: 13668-117-90), b) 1000-count (NDC: 13668-117-10),…
  FDA Drug · Class II · 2019-05-08 · Torrent Pharma
  Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
• Losartan Potassium Tablets, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b)1000-count (NDC: 13668-115-10) per bottle, Rx only, Manufacture…
  FDA Drug · Class II · 2019-05-08 · Torrent Pharma
  Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
• Losartan Potassium Tablets, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b)1000-count (NDC: 13668-113-10) per bottle, Rx only, Manufactured…
  FDA Drug · Class II · 2019-05-08 · Torrent Pharma
  Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
• Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/25mg, a) 30-count (NDC: 13668-118-30) b) 90-count (NDC: 13668-118-90), c) 10…
  FDA Drug · Class II · 2019-05-08 · Torrent Pharma
  Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
• Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/12.5mg, a) 30-count (NDC: 13668-117-30), b) 90-count (NDC: 13668-117-90) per bo…
  FDA Drug · Class II · 2019-04-17 · Torrent Pharma
  Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
• LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count (NDC: 13668-409-30), b) 90-count (NDC: 13668-409-90), c) 1000-count (NDC: 13668-409-10)…
  FDA Drug · Class II · 2019-04-17 · Torrent Pharma
  Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
• Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, a) 30-count (NDC: 13668-118-30), b) 90-count (NDC: 13668-118-90), c) 1000…
  FDA Drug · Class II · 2019-04-17 · Torrent Pharma
  Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
• Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b) 90-count (NDC: 13668-116-90), c) 100…
  FDA Drug · Class II · 2019-04-17 · Torrent Pharma
  Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
• LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b) 1000-count (NDC: 13668-115-10), per bottle, Rx only, Manufactu…
  FDA Drug · Class II · 2019-04-17 · Torrent Pharma
  Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
• LOSARTAN POTASSIUM TABLETS, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b) 1000-count (NDC: 13668-113-10), per bottle, Rx only, Manufactur…
  FDA Drug · Class II · 2019-04-17 · Torrent Pharma
  Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
• LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-113-90), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-…
  FDA Drug · Class II · 2019-02-27 · Torrent Pharma
  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.
• LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP, 100 mg/12.5 mg, a) 90-count bottle (NDC: 13668-117-90), b) 1000-count bottle (NDC:…
  FDA Drug · Class II · 2019-02-27 · Torrent Pharma
  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.
• LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count bottle (NDC: 13668-409-30), b) 90-count bottle (NDC: 13668-409-90), c) 1000-count bottl…
  FDA Drug · Class II · 2019-02-27 · Torrent Pharma
  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.
• LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 30-count (NDC: 13668-115-30), b) 90-count (NDC: 13668-115-90), c) 1000-count (NDC: 13668-115-10…
  FDA Drug · Class II · 2019-02-27 · Torrent Pharma
  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.
• LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5 mg, a) 90-count bottle (NDC: 13668-116-90), b) 1000-count bottle (NDC: 1…
  FDA Drug · Class II · 2019-02-27 · Torrent Pharma
  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.
• Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT PHARMA INC., 150 All…
  FDA Drug · Class II · 2018-09-26 · Torrent Pharma
  Reason: Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
• Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pha…
  FDA Drug · Class II · 2018-09-05 · Torrent Pharma
  Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
• Valsartan Tablets USP, 80mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India
  FDA Drug · Class II · 2018-09-05 · Torrent Pharma
  Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
• Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent P…
  FDA Drug · Class II · 2018-09-05 · Torrent Pharma
  Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
• Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent…
  FDA Drug · Class II · 2018-09-05 · Torrent Pharma
  Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
• Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Ph…
  FDA Drug · Class II · 2018-09-05 · Torrent Pharma
  Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
• Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-3…
  FDA Drug · Class II · 2018-09-05 · Torrent Pharma
  Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
• Amlodipine and Valsartan Tablets, USP, 10 mg/160mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-3…
  FDA Drug · Class II · 2018-09-05 · Torrent Pharma
  Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
• Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-3…
  FDA Drug · Class II · 2018-09-05 · Torrent Pharma
  Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
• Valsartan Tablets USP, 160mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India
  FDA Drug · Class II · 2018-09-05 · Torrent Pharma
  Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
• Valsartan Tablets USP, 320mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India
  FDA Drug · Class II · 2018-09-05 · Torrent Pharma
  Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
• Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Ph…
  FDA Drug · Class II · 2018-09-05 · Torrent Pharma
  Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
• Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-…
  FDA Drug · Class II · 2018-09-05 · Torrent Pharma
  Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
• Olanzapine Tablets, USP, 10 mg, Rx Only, 30 tablets per bottle, Mfd for: Prasco Laboratories, Mason OH, 45040, USA, Mfd by: Torrent Pharmac…
  FDA Drug · Class II · 2013-08-07 · Torrent Pharma
  Reason: 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 app…