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Glenmark Pharmaceuticals Inc., USA Recalls
141 recalls on record · February 7, 2018 to August 5, 2026 · Drugs
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 5, 2026DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA,
Hazard: CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
June 24, 2026DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister
Hazard: Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
January 7, 2026DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Ma
Hazard: Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
December 17, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Prad
Hazard: Cross Contamination with Other Products
December 10, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-87
Hazard: Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
October 22, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg, 3 Blister
Hazard: Failed Impurities/Degradation Specifications
October 1, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colval
Hazard: CGMP Deviations: Market complaints received for gritty texture (grainy)
August 20, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No
Hazard: CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
August 20, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot
Hazard: CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
August 20, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limite
Hazard: Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.
August 20, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez
Hazard: CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
August 20, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bard
Hazard: CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
August 20, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC 68462-162
Hazard: CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
June 18, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd.,
Hazard: Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.
June 4, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark Ph
Hazard: OOS results reported for the Dissolution (by UV) test.
June 4, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured f
Hazard: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
June 4, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured
Hazard: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
June 4, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx Only,
Hazard: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
June 4, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05),
Hazard: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Propafenone Hydrochloride Extended-Release Capsules, USP 325mg,60-count bottles, Rx Only, Mfd for: Northstar Rx LLC, Mem
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Propafenone Hydrochloride Extended-Release Capsules USP, 225mg 60-count bottles, Rx Only, Mfd by: Glenmark Pharmaceutica
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b). 500-count bottle (NDC 16714-570-02), Rx On
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Pravastatin Sodium Tablets, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Dis
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count pack
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pith
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Saxagliptin Tablets, USP, 2.5mg, a). 30-count bottle (NDC# 68462-726-30), b).90-count bottle(NDC# 68462-726-90), Manufac
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Clindamycin Hydrochloride Capsules, USP, 300mg, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pi
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Lacosamide Tablets 150mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 100-count bottle, Rx, Only. Manufactured by: Glenmark Phar
Hazard: CGMP Deviations