Recall archive
19 recalls · page 1 of 1
Reported Jun 11, 2025
Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Torrent Pharma Inc.
Matched: Brand · Product · Product details — CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported May 11, 2022
Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per bottle, Manufactured by: Torrent…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Torrent Pharma Inc.
Matched: Brand · Product · Product details — CGMP deviations: tablets cracking
FDA (openFDA drug enforcement)
Reported Jan 19, 2022
Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactured by: Torrent Pharmaceuticals Ltd.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Torrent Pharma Inc.
Matched: Brand · Product · Product details — Failed Dissolution Specifications
FDA (openFDA drug enforcement)
Reported Dec 22, 2021
Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, 30 count bottles, Rx only, Manufactured by: Torrent…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Torrent Pharma Inc.
Matched: Brand · Product · Product details — Superpotent; Hydrochlorothiazide
FDA (openFDA drug enforcement)
Reported Dec 9, 2020
Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Torrent Pharma Inc.
Matched: Brand · Product · Product details — Failed Dissolution Specifications
FDA (openFDA drug enforcement)
Reported Jun 10, 2020
Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, Manufactured by: Torrent Pharmaceuticals…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Torrent Pharma Inc.
Matched: Brand · Product · Product details — Failed Dissolution Specifications
FDA (openFDA drug enforcement)
Reported Oct 9, 2019
Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Torrent Pharma Inc.
Matched: Brand · Product · Product details — CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable…
3 more products in this recall
FDA (openFDA drug enforcement)
Reported Sep 25, 2019
Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Torrent Pharma Inc.
Matched: Brand · Product · Product details — Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.
FDA (openFDA drug enforcement)
Reported Jun 19, 2019
RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 13668-589-06, Manufactured by Bio-Pharm Inc.,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Torrent Pharma Inc.
Matched: Brand · Product · Product details — cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
40 more products in this recall
FDA (openFDA drug enforcement)
Reported May 22, 2019
Losartan Potassium Tab. USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and b) 90 count bottle (NDC 68788-0048-09), Rx…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Preferred Pharmaceuticals, Inc.
Matched: Brand · Product details — CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable…
FDA (openFDA drug enforcement)
Reported May 8, 2019
Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Legacy Pharmaceutical Packaging LLC
Matched: Brand · Product details · Reason for recall — CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)
FDA (openFDA drug enforcement)
Reported May 8, 2019
Losartan Potassium Tablets, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b)1000-count (NDC: 13668-113-10) per bottle,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Torrent Pharma Inc.
Matched: Brand · Product details — CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable…
5 more products in this recall
FDA (openFDA drug enforcement)
Reported Apr 17, 2019
LOSARTAN POTASSIUM TABLETS, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b) 1000-count (NDC: 13668-113-10), per bottle,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Torrent Pharma Inc.
Matched: Brand · Product details — CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable…
5 more products in this recall
FDA (openFDA drug enforcement)
Reported Apr 10, 2019
Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Legacy Pharmaceutical Packaging LLC
Matched: Brand · Product details — CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected.
FDA (openFDA drug enforcement)
Reported Mar 27, 2019
Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottle (NDC: 68788-0048-03), b) 90-count bottle (NDC:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Preferred Pharmaceuticals, Inc.
Matched: Brand · Product details — CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified.
FDA (openFDA drug enforcement)
Reported Feb 27, 2019
LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 30-count (NDC: 13668-115-30), b) 90-count (NDC: 13668-115-90), c)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Torrent Pharma Inc.
Matched: Brand · Product details — CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the…
4 more products in this recall
FDA (openFDA drug enforcement)
Reported Sep 26, 2018
Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Torrent Pharma Inc.
Matched: Brand · Product · Product details — Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
FDA (openFDA drug enforcement)
Reported Sep 5, 2018
Valsartan Tablets USP, 80mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Torrent Pharma Inc.
Matched: Brand · Product · Product details — CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
11 more products in this recall
FDA (openFDA drug enforcement)
Reported Apr 27, 2016
Telmisartan Tablets, USP, 80 mg, 30-count (3 x 10 unit-dose blisters) per carton, Rx only, Manufactured by: Torrent…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Torrent Pharmaceuticals Limited
Matched: Brand · Product · Product details — Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as silicone within the tablet.
FDA (openFDA drug enforcement)
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