Levittown, PA, United States
Torrent Pharma Inc recalls
14 recalls recorded since 2018, most recently on 27 May 2025. 5 are listed as ongoing. Status and classification are as published by the FDA.
Recalls14
Ongoing (FDA)5
Terminated or completed9
Class I (FDA)1
Completed Class II Drugs
- Recall started
- 27 May 2025
- Reason
- CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
- Distribution
- U.S. Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0456-2025, D-0455-2025
- Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-91 (Cart
- Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-30
Terminated Class II Drugs
- Recall started
- 11 April 2022
- Terminated
- 25 July 2023
- Reason
- CGMP deviations: tablets cracking
- Distribution
- Nationwide in the U.S.A
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0852-2022
- Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per bottle, Manufactured by: Torrent Pharmaceuticals Ltd., Indrad-382 721, India, Manufactured for: Torrent Pharma Inc., Levittown, PA 19057, N
Terminated Class II Drugs
- Recall started
- 2 December 2021
- Terminated
- 23 October 2023
- Reason
- Failed Dissolution Specifications
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0365-2022
- Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactured by: Torrent Pharmaceuticals Ltd. Bharuch-392130, India Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920.
Terminated Class III Drugs
- Recall started
- 1 December 2021
- Terminated
- 12 May 2024
- Reason
- Superpotent; Hydrochlorothiazide
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0285-2022
- Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, 30 count bottles, Rx only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ
Terminated Class I Drugs
- Recall started
- 25 November 2020
- Terminated
- 28 December 2022
- Reason
- Failed Dissolution Specifications
- Distribution
- Nationwide USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0166-2021
- Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920 NDC 13668-462-01
Terminated Class II Drugs
- Recall started
- 11 May 2020
- Terminated
- 10 August 2022
- Reason
- Failed Dissolution Specifications
- Distribution
- USA Nationwide and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1317-2020
- Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd, Bharuch 392130, India; Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC 13668-2
Ongoing Class II Drugs
- Recall started
- 19 September 2019
- 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 of 9.82 parts per million.
- Distribution
- Nationwide USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0124-2020, D-0123-2020, D-0121-2020, D-0122-2020
- Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-118-90
- Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-116-90
- Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-409-10
- Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC 90 tablets: 13668-115-90; NDC 1000 tablets: 13668-115-10
Terminated Class II Drugs
- Recall started
- 6 September 2019
- Terminated
- 3 November 2020
- Reason
- Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.
- Distribution
- Nationwide in the USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1862-2019
- Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC 13668-453-01.
Terminated Class II Drugs
- Recall started
- 21 May 2019
- Terminated
- 6 October 2020
- Reason
- cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- Distribution
- Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1371-2019, D-1367-2019, D-1375-2019, D-1359-2019, D-1369-2019, D-1373-2019, D-1378-2019, D-1346-2019, D-1368-2019, D-1352-2019, D-1383-2019, D-1382-2019 and 29 more
- Nasal Decongestant Liquid, Pseudoephedrine HCl, 30 mg in each teaspoonful, 4 Fl. oz. (118 mL) bottle, NDC:0536-1850-97, Distributed by Rugby Laboratories, Livonia MI 48152.
- Kid Kare Childrens Cough/Cold Liquid, Antihistamine, Cough Suppressant, Nasal Decongestant, Cherry Flavored, Alcohol Free, (Chlorpheniramine Maleate, USP 2 mg, Dextromethorphan HBr, USP 10 mg, Pseudoephedrine HCl, USP 3
- Memantine Hydrochloride Oral Solution, 2 mg/mL, Rx Only, 12 FL. oz.. bottle, NDC: 13668-573-09, Manufactured By Bio-Pharm Inc., Levittown, PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920.
- 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.
- Extra Action Cough Syrup (Guaifenesin and Dextromethorphan HBr Syrup) 100 mg/10 mg per 5 mL, a) 4 FL. oz. (118 mL) bottle, NDC: 0536-0970-97, b) One Pint (473 mL) bottle, 0536-0970-85, Distributed by Rugby Laboratories,
- Lactulose Solution, USP 10 g/15 mL, For Oral or Rectal Administration, Rx Only, 16 FL. oz. Bottle, NDC:13668-574-10, Manufactured By Bio-Pharm, Levittown, PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ
- Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 Rectal Suppositories per carton, NDC: 0536-1389-12, Distributed by Rugby Laboratories, Livonia MI 48152 USA.
- Children's Acetaminophen Liquid, 160 mg per 5 mL, Fever and Pain, Alcohol free, aspirin free, ibuprofen free, Cherry Flavor, 4 FL. oz. (118 mL) bottle, NDC: 59741-101-06, Manufactured by Bio-Pharm, Inc., Levittown PA 190
- and 33 more product lines
Ongoing Class II Drugs
- Recall started
- 18 April 2019
- 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.
- Distribution
- Nationwide USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1266-2019, D-1264-2019, D-1267-2019, D-1269-2019, D-1265-2019, D-1268-2019
- Losartan Potassium Tablets, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b)1000-count (NDC: 13668-115-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
- 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 by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
- Losartan Potassium and Hydrochlorothiazide Tablets, USP, 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b) 90-count (NDC: 13668-116-90), c) 1000-count (NDC: 13668-116-10), per bottle, Rx only, Manufactured by: Torrent Pha
- Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/25mg, a) 30-count (NDC: 13668-118-30) b) 90-count (NDC: 13668-118-90), c) 1000-count (NDC: 13668-118-10), per bottle, Rx only, Manufactured by: Torrent Pharm
- 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 by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
- Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/12.5mg, a) 90-count (NDC: 13668-117-90), b) 1000-count (NDC: 13668-117-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721
Ongoing Class II Drugs
- Recall started
- 28 February 2019
- 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.
- Distribution
- Nationwide USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1118-2019, D-1119-2019, D-1116-2019, D-1115-2019, D-1114-2019, D-1117-2019
- Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/12.5mg, a) 30-count (NDC: 13668-117-30), b) 90-count (NDC: 13668-117-90) per bottle , Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Di
- Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, a) 30-count (NDC: 13668-118-30), b) 90-count (NDC: 13668-118-90), c) 1000-count (NDC: 13668-118-10) per bottle , Rx only, Manufactured by: Torrent Pharma
- LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b) 1000-count (NDC: 13668-115-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For:
- 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), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382
- 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 by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: To
- Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b) 90-count (NDC: 13668-116-90), c) 1000-count (NDC: 13668-116-10) per bottle , Rx only, Manufactured by: Torrent Pharm
Ongoing Class II Drugs
- Recall started
- 20 December 2018
- 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.
- Distribution
- Nationwide USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0503-2019, D-0501-2019, D-0504-2019, D-0505-2019, D-0502-2019
- LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-113-90), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
- 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) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 7
- LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP, 100 mg/12.5 mg, a) 90-count bottle (NDC: 13668-117-90), b) 1000-count bottle (NDC: 13668-117-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-38
- LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5 mg, a) 90-count bottle (NDC: 13668-116-90), b) 1000-count bottle (NDC: 13668-116-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382
- 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 bottle (NDC: 13668-409-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Ind
Terminated Class II Drugs
- Recall started
- 11 September 2018
- Terminated
- 4 September 2020
- Reason
- Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1204-2018
- Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920. NDC: 13668-342-30
Ongoing Class II Drugs
- Recall started
- 17 August 2018
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1138-2018, D-1145-2018, D-1137-2018, D-1135-2018, D-1142-2018, D-1140-2018, D-1136-2018, D-1134-2018, D-1141-2018, D-1139-2018, D-1144-2018, D-1143-2018
- Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-205-30
- Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-329-30
- Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-204-30
- Valsartan Tablets USP, 160mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-069-90
- Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-326-30
- Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-207-30
- Valsartan Tablets USP, 320mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-070-90
- Valsartan Tablets USP, 80mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-068-90
- and 4 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.