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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.
July 24, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenma
Hazard: CGMP Deviations
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: Failed Dissolution Specifications
July 24, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenma
Hazard: Failed Dissolution Specifications
June 12, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark P
Hazard: CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
June 12, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Ph
Hazard: CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
June 12, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Rizatriptan Benzoate Tablets USP, 10 mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc.,
Hazard: CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
June 12, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., US
Hazard: CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
May 1, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Man
Hazard: Failed Dissolution Specifications
April 10, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Man
Hazard: Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
January 31, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: Gl
Hazard: Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
December 6, 2023DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, G
Hazard: Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
December 6, 2023DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Barde
Hazard: Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
November 29, 2023DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-c
Hazard: Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time point in long term stability study (25¿C/60% RH).
November 15, 2023DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Manufactured for: Glenmark Pharmaceuticals Inc
Hazard: Failed Dissolution Specifications
November 15, 2023DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Lim
Hazard: Failed Dissolution Specifications: Out of specification for dissolution.
November 8, 2023DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by: Glenma
Hazard: Failed Impurities/Degradation Specifications
August 30, 2023DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, Manufactured
Hazard: Subpotent: Out of Specification for Assay Test at the 3-month time point.
August 17, 2022DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceu
Hazard: Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
August 17, 2022DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/25 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuti
Hazard: Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
August 10, 2022DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35,
Hazard: Defective Container: Tube split from side seam
July 27, 2022DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Aspirin and Extended-Release Dipyridamole Capsules, 25mg/200 mg, 60-count bottle, Rx Only, Manufactured for: Glenmark Ph
Hazard: Failed Tablet/Capsule Specification : Capsule breakage
July 13, 2022DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC 68462-385-37), b) 60 ml-bottle (NDC 68462-3
Hazard: Defective Container
July 6, 2022DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141,
Hazard: CGMP Deviations
May 4, 2022DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01); b) 500-count bottle (NDC 68462-13
Hazard: cGMP deviations
May 4, 2022DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Zonisamide Capsules, USP, 50 mg, packaged in 100-count bottles, Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc.
Hazard: cGMP deviations
May 4, 2022DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Zonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals, Inc.,
Hazard: cGMP deviations
September 29, 2021DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation Only Rx Only Manufactured by: Glenmark Pharma
Hazard: Lack of Assurance of Sterility
September 29, 2021DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured
Hazard: CGMP Deviations
September 29, 2021DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC 68462-129-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA
Hazard: CGMP Deviations
September 29, 2021DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC 68462-725-01 Manufactured by: Glenmark Pharmaceuticals Inc., U
Hazard: CGMP Deviations