Torrent Pharma recalls
FDA enforcement reports naming Torrent Pharma Inc as the recalling firm.
- Recall reports
- 84
- Class I (serious)
- 1
- Most recent report
- Jun 11, 2025
- Jun 11, 2025Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHA…Drug · Torrent Pharma Inc.CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.Class II
- Jun 11, 2025Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRE…Drug · Torrent Pharma Inc.CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.Class II
- May 11, 2022Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per bottle…Drug · Torrent Pharma IncCGMP deviations: tablets crackingClass II
- Jan 19, 2022Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactured by:…Drug · Torrent Pharma Inc.Failed Dissolution SpecificationsClass II
- Dec 22, 2021Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12Drug · Torrent Pharma Inc.Superpotent; HydrochlorothiazideClass III
- Dec 9, 2020Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India for: Torren…Drug · Torrent Pharma IncFailed Dissolution SpecificationsClass I
- Jun 10, 2020Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, Manufacture…Drug · Torrent Pharma Inc.Failed Dissolution SpecificationsClass II
- Oct 9, 2019Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx Only, Manuf…Drug · Torrent Pharma Inc.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.Class II
- Oct 9, 2019Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manufactured fo…Drug · Torrent Pharma Inc.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.Class II
- Oct 9, 2019Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle,…Drug · Torrent Pharma Inc.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.Class II
- Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12
- Anagrelide Capsules, USP, 0
- Hemorrhoidal Suppositories (Phenylephrine HCl 0
- Nasal Decongestant Spray Regular, Oxymetazoline HCl 0
- Robafen DM Cough Sugar-Free Clear Cough Expectorant (Dextromethorphan HBr, USP 20 mg),…
- Pedia Relief Cough-Cold Oral Solution, Alcohol free, antihistamine, cough suppressant,…
- Biscolax Laxative (Bisacodyl, USP 10 mg), a) 12 suppositories per carton
- Cyproheptadine Hydrochloride Syrup Oral Solution, USP, 2mg/5mL, 473 mL (16 FL
- Hyoscyamine Oral Drops 0
- Hyoscyamine Sulfate Elixir 0
- Cetirizine HCL Oral Solution, USP 1mg/mL, 4 oz - BULK, PLD
- Acetic Acid Otic Solution, USP, 2%, Rx Only, 15 mL bottle, NDC: 64980-424-15, Manufact…
- Guaifenesin AC Cough Syrup (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 m…
- Guaifenesin DAC Oral Solution, Sugar free, (Guaifenesin, Pseudoephedrine HCl and Codei…
- Phenobarbital Oral Solution, USP, 20 mg per 5 mL, Rx Only, One Pint (473 mL) bottle
- Pain & Fever Oral Solution (Acetaminophen 160 mg/5 mL), Sugar free, Aspirin & Alcohol f…
- Kid Kare Childrens Cough/Cold Liquid, Antihistamine, Cough Suppressant, Nasal Decongest…
- Cough Syrup (Guaifenesin Syrup, USP) 200 mg/10 mL, Alcohol free Non-Narcotic Expectoran…
- Extra Action Cough Syrup (Guaifenesin and Dextromethorphan HBr Syrup) 100 mg/10 mg per…
- Diphenhist Oral Solution (Diphenhydramine HCl, USP), 12
- Nasal Decongestant Liquid, Pseudoephedrine HCl, 30 mg in each teaspoonful, 4 Fl
- Lactulose Solution, USP 10 g/15 mL, For Oral Administration, Rx Only, a) 16 FL
- Lactulose Solution, USP 10 g/15 mL, For Oral or Rectal Administration, Rx Only, 16 FL
- Memantine Hydrochloride Oral Solution, 2 mg/mL, 12 oz
- Memantine Hydrochloride Oral Solution, 2 mg/mL, Rx Only, 12 FL
- Hydrocortisone Acetate Suppositories, 25 mg, Rx Only, For rectal administration, a) 12…
- Laxative Suppositories (Bisacodyl USP, 10 mg), a) 12 Suppositories per carton
- Anu-Med brand of Hemorrhoidal Suppositories (Phenylephrine HCl 0
- Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL, For Oral Use Only, Rx Only, 120 mL…
- Cetirizine Hydrochloride Oral Solution, USP 1mg/mL, Fr Oral Use Only, Rx only, 120 mL b…
- RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle
- Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1
- Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1
- Bisacodyl Suppositories, Brite Stock, Reese
- RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle
- Children's Acetaminophen Liquid, 160 mg per 5 mL, Fever and Pain, Alcohol free, aspirin…
- Allergy Liquid Antihistamine, Diphenhydramine HCl USP 12
- Children's Mapap Acetaminophen Liquid, Fever reducer, Pain reliever, Alcohol free, Aspi…
- Robafen Cough Formula Expectorant (guaifenesin USP 200 mg in each 10 mL), a) 4 Fl
- Robafen AC Oral Solution (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/…
- Robafen DM Syrup (Dextromethorphan HBr, USP 20 mg/10 mL and Guaifenesin, USP 200 mg/10…
- Banophen Oral Solution, Sugar Free, Alcohol Free, Cherry Flavor, (Diphenhydramine HCl,…
- Pseudoephedrine Oral Solution, 30 mg in each teaspoonful, Nasal Decongestant, One Pint…
- Losartan Potassium Tablets, USP, 50 mg, a) 90-count (NDC: 13668-409-90), b)1000-count (…
- Losartan Potassium Tablets, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b)1000-count…
- Losartan Potassium and Hydrochlorothiazide Tablets, USP, 50mg/12
- Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/12
- Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/25mg, a) 30-count (NDC:…
- Losartan Potassium Tablets, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b)1000-count (…
- LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count (NDC: 13668-409-30), b) 90-count (N…
- LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b) 1000-count…
- Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12
- Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/12
- Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, a) 30-count (NDC: 13…
- LOSARTAN POTASSIUM TABLETS, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b) 1000-count…
- LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 30-count (NDC: 13668-115-30), b) 90-count (…
- LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count bottle (NDC: 13668-409-30), b) 90-c…
- LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-113-90), Rx only, M…
- LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP, 100 mg/12
- LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12
- Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manu…
- Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 mg, 30 tabl…
- Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/12
- Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/12
- Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 mg, 30 tabl…
- Valsartan Tablets USP, 80mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent P…
- Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30 tablets per bottle, Rx Only, Man…
- Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/25 mg, 30 table…
- Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg, 30 tablets per bottle, Rx Only, Man…
- Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30 tablets per bottle, Rx Only, Ma…
- Valsartan Tablets USP, 320mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent…
- Valsartan Tablets USP, 160mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent…
- Amlodipine and Valsartan Tablets, USP, 10 mg/160mg, 30 tablets per bottle, Rx Only, Man…
- Olanzapine Tablets, USP, 10 mg, Rx Only, 30 tablets per bottle, Mfd for: Prasco Laborat…
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