Home / Companies / Glenmark Pharmaceuticals Inc., USA

Glenmark Pharmaceuticals Inc., USA

FDA Regulatory Profile

Summary

Total Recalls
139 (2 Class I)
510(k) Clearances
0
Inspections
3
Compliance Actions
3

Known Names

glenmark pharmaceuticals inc., usa, glenmark pharmaceuticals inc usa, glenmark pharmaceuticals inc. usa

Recent Recalls

NumberClassProductDate
D-0246-2026Class IIOndansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tDecember 30, 2025
D-0199-2026Class IIIBisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bNovember 21, 2025
D-0222-2026Class IIINebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, PiNovember 18, 2025
D-0662-2025Class IIAzelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark PharmaceutSeptember 17, 2025
D-0021-2026Class IIViorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USPSeptember 3, 2025
D-0583-2025Class IITheophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark PhAugust 8, 2025
D-0578-2025Class IICarvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark PharmaceuticaAugust 7, 2025
D-0577-2025Class IICarvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bAugust 7, 2025
D-0579-2025Class IICarvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark PharmaceuticalsAugust 7, 2025
D-0588-2025Class IICarvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark PharmaceuAugust 6, 2025
D-0587-2025Class IICarvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark PharmacAugust 6, 2025
D-0462-2025Class IIIEzetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark PhMay 19, 2025
D-0452-2025Class IITheophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, ManufactMay 15, 2025
D-0349-2025Class IIPravastatin Sodium Tablets, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: Northstar Rx LLC, MemphMarch 13, 2025
D-0333-2025Class IISolifenacin Succinate Tablets 5mg, a.) 30-count bottle (NDC# 68462-386-30) b.) 90-count bottle (NDC#March 13, 2025
D-0323-2025Class IIRufinamide Tablets 200mg, 120-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals LimitMarch 13, 2025
D-0318-2025Class IIVoriconazole Tablets 200 mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals LimMarch 13, 2025
D-0332-2025Class IISaxagliptin Tablets 5mg, a). 30-count bottle (NDC# 68462-727-30) b.) 90-count bottle ( 68462-727-90)March 13, 2025
D-0330-2025Class IILacosamide Tablets, 100mg , 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals LimiMarch 13, 2025
D-0348-2025Class IICetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark ThMarch 13, 2025