Torrent Pharma Inc

Complete recall history across all FDA and CPSC categories — 44 total recalls

Torrent Pharma Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (44)

FDA drug safety enforcement actions by Torrent Pharma Inc

Date Product Reason Class
Apr 11, 2022 Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets ... CGMP deviations: tablets cracking Class II
Nov 25, 2020 Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India f... Failed Dissolution Specifications Class I
May 21, 2019 Biscolax Laxative (Bisacodyl, USP 10 mg), a) 12 suppositories per carton, NDC... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Pedia Relief Cough-Cold Oral Solution, Alcohol free, antihistamine, cough sup... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Nasal Decongestant Spray Regular, Oxymetazoline HCl 0.05%, a) 0.5 FL. oz. (15... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Allergy Liquid Antihistamine, Diphenhydramine HCl USP 12.5 mg/5 mL), Alcohol ... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Hyoscyamine Sulfate Elixir 0.125 mg per 5 mL, Rx Only, 473 mL (16 oz.) bottle... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Phenobarbital Oral Solution, USP, 20 mg per 5 mL, Rx Only, One Pint (473 mL) ... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Robafen DM Syrup (Dextromethorphan HBr, USP 20 mg/10 mL and Guaifenesin, USP ... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Diphenhist Oral Solution (Diphenhydramine HCl, USP), 12.5 mg/5 mL, a) 4 FL. o... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Cetirizine HCL Oral Solution, USP 1mg/mL, 4 oz - BULK, PLD cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Robafen DM Cough Sugar-Free Clear Cough Expectorant (Dextromethorphan HBr, US... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Bisacodyl Suppositories, Brite Stock, Reese. cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Cetirizine Hydrochloride Oral Solution, USP 1mg/mL, Fr Oral Use Only, Rx only... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Lactulose Solution, USP 10 g/15 mL, For Oral Administration, Rx Only, a) 16 F... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Guaifenesin AC Cough Syrup (Guaifenesin and Codeine Phosphate Oral Solution, ... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Cyproheptadine Hydrochloride Syrup Oral Solution, USP, 2mg/5mL, 473 mL (16 FL... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Pain & Fever Oral Solution (Acetaminophen 160 mg/5 mL), Sugar free, Aspirin &... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Robafen AC Oral Solution (Guaifenesin and Codeine Phosphate Oral Solution, US... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 13668-589... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Laxative Suppositories (Bisacodyl USP, 10 mg), a) 12 Suppositories per carton... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Hydrocortisone Acetate Suppositories, 25 mg, Rx Only, For rectal administrati... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Children's Mapap Acetaminophen Liquid, Fever reducer, Pain reliever, Alcohol ... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Guaifenesin DAC Oral Solution, Sugar free, (Guaifenesin, Pseudoephedrine HCl... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Pseudoephedrine Oral Solution, 30 mg in each teaspoonful, Nasal Decongestant,... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Acetic Acid Otic Solution, USP, 2%, Rx Only, 15 mL bottle, NDC: 64980-424-15... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Robafen Cough Formula Expectorant (guaifenesin USP 200 mg in each 10 mL), a) ... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Memantine Hydrochloride Oral Solution, 2 mg/mL, 12 oz. bottle, NDC: 39328-551... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Anu-Med brand of Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fa... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL, For Oral Use Only, Rx On... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 ... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 23155-317... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 ... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Banophen Oral Solution, Sugar Free, Alcohol Free, Cherry Flavor, (Diphenhydra... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Cough Syrup (Guaifenesin Syrup, USP) 200 mg/10 mL, Alcohol free Non-Narcotic ... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Children's Acetaminophen Liquid, 160 mg per 5 mL, Fever and Pain, Alcohol fre... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 Rect... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Lactulose Solution, USP 10 g/15 mL, For Oral or Rectal Administration, Rx Onl... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Extra Action Cough Syrup (Guaifenesin and Dextromethorphan HBr Syrup) 100 mg/... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Hyoscyamine Oral Drops 0.125 mg/mL, Rx Only, 15 mL bottle (0.5 FL. oz.), NDC:... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Memantine Hydrochloride Oral Solution, 2 mg/mL, Rx Only, 12 FL. oz.. bottle, ... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Kid Kare Childrens Cough/Cold Liquid, Antihistamine, Cough Suppressant, Nasal... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
May 21, 2019 Nasal Decongestant Liquid, Pseudoephedrine HCl, 30 mg in each teaspoonful, 4 ... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B... Class II
Jul 22, 2013 Olanzapine Tablets, USP, 10 mg, Rx Only, 30 tablets per bottle, Mfd for: Pras... Defective Container; This action is being taken as a precautionary measure du... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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