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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.
February 26, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, M
Hazard: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
February 26, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, M
Hazard: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
February 26, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, M
Hazard: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
February 26, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, M
Hazard: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
February 26, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, M
Hazard: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
February 26, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, M
Hazard: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
February 26, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA
Hazard: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
February 26, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA,
Hazard: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
February 26, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA,
Hazard: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
February 26, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA,
Hazard: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
February 26, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA,
Hazard: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
February 26, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA,
Hazard: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
February 26, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA,
Hazard: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
February 12, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactur
Hazard: CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
February 12, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured
Hazard: CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
January 1, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals
Hazard: CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
January 1, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals I
Hazard: CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
December 11, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd
Hazard: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
December 11, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd f
Hazard: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
December 11, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd
Hazard: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
December 11, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 Capsules, Manufactured for: Glenmark Pharmac
Hazard: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
December 11, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules, Manufactured for : Glenmark Pharmac
Hazard: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
December 11, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Manu
Hazard: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
October 9, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665 mcg/25 mcg per spray, 240 Metered Sprays/b
Hazard: Defective Delivery System: The dip tube is clogged causing the spray not to work.
October 9, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only, a) 30 gm Tube, NDC 68462-0455-35; b) 45 g
Hazard: Defective Container: Firm received complaints of broken tube at the seal.
October 2, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Mupirocin Ointment, USP, 2%, 22 g, Rx only, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513,
Hazard: Subpotent Drug
September 4, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC 68462-325-60) and b) 90-count b
Hazard: Failed Dissolution Specifications: below specification results
August 7, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez,
Hazard: CGMP Deviations
July 24, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-1
Hazard: Failed Dissolution Specifications: results below specifications
July 24, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenma
Hazard: CGMP Deviations