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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-0579-2025Class IICarvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark PharmaceuticalsAugust 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-0587-2025Class IICarvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark PharmacAugust 6, 2025
D-0588-2025Class IICarvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark PharmaceuAugust 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-0350-2025Class IIPravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b). 500-count bottle (NDC March 13, 2025
D-0321-2025Class IILacosamide Tablets 200mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals LimiteMarch 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-0324-2025Class IINitroglycerin Sublingual Tablets 0.4MG 100-count carton, Rx Only, Manufactured by: Glenmark PharmacMarch 13, 2025
D-0341-2025Class IIPravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count bottle (NDC#March 13, 2025
D-0335-2025Class IIRanolazine Extended-Release Tablets 1000mg, 60-count bottle, Rx Only, Manufactured by: Glenmark PhMarch 13, 2025
D-0320-2025Class IIGabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals LimiMarch 13, 2025