Records and reported status
Mar 13, 2025 FDA drug enforcement
CGMP Deviations
Class II Reported ongoing
Distribution: U.S. Nationwide
Official source for Rosuvastatin Tablets 40mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Li... Mar 13, 2025 FDA drug enforcement
CGMP Deviations
Class II Reported ongoing
Distribution: U.S. Nationwide
Official source for Colesvelam Hydrocholoride Tablets 625mg, 180-count bottle, Rx Only, Manufactured by: Glenmark Pha... Mar 13, 2025 FDA drug enforcement
CGMP Deviations
Class II Reported ongoing
Distribution: U.S. Nationwide
Official source for Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count bottle (N... Mar 13, 2025 FDA drug enforcement
CGMP Deviations
Class II Reported ongoing
Distribution: U.S. Nationwide
Official source for Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 100-count bottle, Rx, Only. Manufac... Mar 13, 2025 FDA drug enforcement
CGMP Deviations
Class II Reported ongoing
Distribution: U.S. Nationwide
Official source for Lacosamide Tablets 150mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Lim... Mar 13, 2025 FDA drug enforcement
CGMP Deviations
Class II Reported ongoing
Distribution: U.S. Nationwide
Official source for Clindamycin Hydrochloride Capsules, USP, 300mg, 100-count bottles, Manufactured by: Glenmark Phar... Mar 13, 2025 FDA drug enforcement
CGMP Deviations
Class II Reported ongoing
Distribution: U.S. Nationwide
Official source for Saxagliptin Tablets, USP, 2.5mg, a). 30-count bottle (NDC# 68462-726-30), b).90-count bottle(NDC#... Mar 13, 2025 FDA drug enforcement
CGMP Deviations
Class II Reported ongoing
Distribution: U.S. Nationwide
Official source for Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharma... Mar 13, 2025 FDA drug enforcement
CGMP Deviations
Class II Reported ongoing
Distribution: U.S. Nationwide
Official source for Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-... Mar 13, 2025 FDA drug enforcement
CGMP Deviations
Class II Reported ongoing
Distribution: U.S. Nationwide
Official source for Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark... Mar 13, 2025 FDA drug enforcement
CGMP Deviations
Class II Reported ongoing
Distribution: U.S. Nationwide
Official source for Pravastatin Sodium Tablets, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: Northstar Rx LLC, Me... Mar 13, 2025 FDA drug enforcement
CGMP Deviations
Class II Reported ongoing
Distribution: U.S. Nationwide
Official source for Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b). 500-count bottle (N... Mar 13, 2025 FDA drug enforcement
CGMP Deviations
Class II Reported ongoing
Distribution: U.S. Nationwide
Official source for Propafenone Hydrochloride Extended-Release Capsules USP, 225mg 60-count bottles, Rx Only, Mfd by:... Mar 13, 2025 FDA drug enforcement
CGMP Deviations
Class II Reported ongoing
Distribution: U.S. Nationwide
Official source for Propafenone Hydrochloride Extended-Release Capsules, USP 325mg,60-count bottles, Rx Only, Mfd for... Mar 11, 2025 FDA drug enforcement
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Class II Reported ongoing
Distribution: Nationwide in the USA and PR
Official source for chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured f... Feb 28, 2025 FDA drug enforcement
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class II Reported ongoing
Distribution: U.S. Nationwide
Official source for Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bott... Feb 28, 2025 FDA drug enforcement
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class II Reported ongoing
Distribution: U.S. Nationwide
Official source for Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC... Feb 28, 2025 FDA drug enforcement
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class II Reported ongoing
Distribution: U.S. Nationwide
Official source for Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceutic... Feb 28, 2025 FDA drug enforcement
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class II Reported ongoing
Distribution: U.S. Nationwide
Official source for Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceutica... Jan 29, 2025 FDA drug enforcement
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II Reported ongoing
Distribution: Nationwide within the U.S
Official source for Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmac...
Reasons in these listed records CGMP Deviations CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit. CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. These examples come from this result page and are not a ranking of every recall reason.
Checking Glenmark Pharmaceuticals Inc., USA Is there a recall on glenmark pharmaceuticals inc., usa right now? This archive contains 116 records, including 105 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Where can I find older records? Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.