Glenmark Pharmaceuticals Inc., USA recalls

86 recalls on record · latest: December 30, 2025

Official U.S. recall history for Glenmark Pharmaceuticals Inc., USA, compiled from official government records.

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Glenmark Pharmaceuticals Inc., USA recalls Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, M…

December 30, 2025 · Drug & medication recalls Moderate risk Defective container: Preferred Pharmaceuticals received a letter from the manuf…

Glenmark Pharmaceuticals Inc., USA recalls Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-8…

November 21, 2025 · Drug & medication recalls Cross Contamination with Other Products: Testing of reserve samples showed pres…

Glenmark Pharmaceuticals Inc., USA recalls Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pra…

November 18, 2025 · Drug & medication recalls Cross Contamination with Other Products

Azelaic Acid Gel recalled over manufacturing violations

September 17, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: Market complaints received for gritty texture (grainy)

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 Bliste…

September 3, 2025 · Drug & medication recalls Moderate risk Failed Impurities/Degradation Specifications

Glenmark Pharmaceuticals Inc., USA recalls Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limit…

August 8, 2025 · Drug & medication recalls Moderate risk Failed Dissolution Specifications: Failure results (above) were reported for th…

Carvedilol Tablets recalled over manufacturing violations

August 7, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity abo…

Carvedilol Tablets recalled over manufacturing violations

August 7, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity abo…

Carvedilol Tablets recalled over manufacturing violations

August 7, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity abo…

Carvedilol Tablets recalled over manufacturing violations

August 6, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity ob…

Carvedilol Tablets recalled over manufacturing violations

August 6, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity ob…

Glenmark Pharmaceuticals Inc., USA recalls Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd.,…

May 19, 2025 · Drug & medication recalls Failed Impurities/Degradation Specifications: Out of Specification (OOS) for re…

Glenmark Pharmaceuticals Inc., USA recalls Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark P…

May 15, 2025 · Drug & medication recalls Moderate risk OOS results reported for the Dissolution (by UV) test.

Fluphenazine Hydrochloride Tablets 2 recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Teriflunomide Tablets recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Solifenacin Succinate Tablets 10MG recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Voriconazole Tablets 200 mg recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Propafenone Hydrochloride Extended-Release Capsules 225mg recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Lacosamide Tablets recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Nitroglycerin Sublingual Tablets 0 recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Clindamycin Hydrochloride Capsules recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Indomethacin Extended-Release Capsules recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Rosuvastatin Tablets 40mg recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Propafenone Hydrochloride Extended-Release Capsules recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Fluphenazine Hydrochloride Tablets recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Lacosamide Tablets 200mg recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Pravastatin Sodium Tablets 80mg recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Rufinamide Tablets 200mg recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Propafenone Hydrochloride Extended-Release Capsules USP recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Carvedilol Tablets recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Pravastatin Sodium Tablets recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Lacosamide Tablets recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Acetaminophen and Ibuprofen Tablets recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Nitroglycerin Sublingual Tablets 0 recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Saxagliptin Tablets 5mg recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Colesvelam Hydrocholoride Tablets 625mg recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Voriconazole Tablets 50mg recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Propafenone Hydrochloride Extended-Release Capsules 325mg recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Lacosamide Tablets 150mg recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Saxagliptin Tablets recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Prochlorperazine Maleate Tablets recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Gabapentin Tablets 600mg recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Solifenacin Succinate Tablets 5mg recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Metformin Hydrochloride Extended-Release Tablets 1000mg recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Pravastatin Sodium Tablets recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Naproxen Sodium Tablets recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Frovatriptan Succinate Tablets 2 recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Fenofibrate Capsules 67 mg recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Pravastatin Sodium Tablets recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Ranolazine Extended-Release Tablets 1000mg recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

Cetirizine Hydrochloride Tablets recalled over manufacturing violations

March 13, 2025 · Drug & medication recalls Moderate risk CGMP Deviations

ChlorproMAZINE Hydrochloride Tablets recalled over manufacturing violations

March 11, 2025 · Drug & medication recalls Moderate risk CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above…

Carvedilol Tablets USP 6 recalled over manufacturing violations

February 28, 2025 · Drug & medication recalls Moderate risk CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommend…

Carvedilol Tablets USP 3 recalled over manufacturing violations

February 28, 2025 · Drug & medication recalls Moderate risk CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommend…

Carvedilol Tablets USP 12 recalled over manufacturing violations

February 28, 2025 · Drug & medication recalls Moderate risk CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommend…

Carvedilol Tablets USP 25 mg recalled over manufacturing violations

February 28, 2025 · Drug & medication recalls Moderate risk CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommend…

Atomoxetine Capsules recalled over manufacturing violations

January 29, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recom…

Atomoxetine Capsules recalled over manufacturing violations

January 29, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recom…

Atomoxetine Capsules recalled over manufacturing violations

January 29, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recom…

Atomoxetine Capsules recalled over manufacturing violations

January 29, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recom…

Atomoxetine Capsules recalled over manufacturing violations

January 29, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recom…

Atomoxetine Capsules recalled over manufacturing violations

January 29, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recom…

Atomoxetine Capsules recalled over manufacturing violations

January 29, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recom…

Atomoxetine Capsules recalled over manufacturing violations

January 29, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recom…

Atomoxetine Capsules recalled over manufacturing violations

January 29, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recom…

Atomoxetine Capsules recalled over manufacturing violations

January 29, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recom…

Atomoxetine Capsules recalled over manufacturing violations

January 29, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recom…

Atomoxetine Capsules recalled over manufacturing violations

January 29, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recom…

Atomoxetine Capsules recalled over manufacturing violations

January 29, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recom…

Atomoxetine Capsules recalled over manufacturing violations

January 29, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recom…

Carvedilol Tablets recalled over manufacturing violations

January 22, 2025 · Drug & medication recalls Moderate risk CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be faili…

Carvedilol Tablets recalled over manufacturing violations

January 22, 2025 · Drug & medication recalls Moderate risk CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be faili…

ChlorproMAZINE Hydrochloride Tablets recalled over manufacturing violations

December 11, 2024 · Drug & medication recalls Moderate risk CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found…

ChlorproMAZINE Hydrochloride Tablets recalled over manufacturing violations

December 11, 2024 · Drug & medication recalls Moderate risk CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found…

Diltiazem Hydrochloride Extended-Release Capsules recalled over manufacturing violations

November 1, 2024 · Drug & medication recalls Moderate risk cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA r…

Diltiazem Hydrochloride Extended-Release Capsules recalled over manufacturing violations

November 1, 2024 · Drug & medication recalls Moderate risk cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA r…

Diltiazem Hydrochloride Extended-Release Capsules recalled over manufacturing violations

November 1, 2024 · Drug & medication recalls Moderate risk cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA r…

Diltiazem Hydrochloride Extended-Release Capsules recalled over manufacturing violations

November 1, 2024 · Drug & medication recalls Moderate risk cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA r…

Diltiazem Hydrochloride Extended-Release Capsules recalled over manufacturing violations

November 1, 2024 · Drug & medication recalls Moderate risk cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA r…

Diltiazem Hydrochloride Extended-Release Capsules recalled over manufacturing violations

November 1, 2024 · Drug & medication recalls Moderate risk cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA r…

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…

September 30, 2024 · Drug & medication recalls Defective Container: Firm received complaints of broken tube at the seal.

Glenmark Pharmaceuticals Inc., USA recalls Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665 mcg/25 mcg per spray, 240 Metered Sprays/…

September 24, 2024 · Drug & medication recalls Moderate risk Defective Delivery System: The dip tube is clogged causing the spray not to wor…

Glenmark Pharmaceuticals Inc., USA recalls Mupirocin Ointment, USP, 2%, 22 g, Rx only, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513…

August 30, 2024 · Drug & medication recalls Moderate risk Subpotent Drug

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…

July 31, 2024 · Drug & medication recalls Moderate risk Failed Dissolution Specifications: below specification results

Glenmark recalled over manufacturing violations

July 22, 2024 · Drug & medication recalls Moderate risk CGMP Deviations