Glenmark Pharmaceuticals Inc., USA Provisional
FDA Flags (123)
Class II RecallJun 2026
Glenmark Pharmaceuticals Inc., USA
Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister
Classification: Class II
Class II RecallJan 2026
Glenmark Pharmaceuticals Inc., USA
Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Ma
Classification: Class II
Class III RecallDec 2025
Glenmark Pharmaceuticals Inc., USA
Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Prad
Classification: Class III
Class III RecallDec 2025
Glenmark Pharmaceuticals Inc., USA
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-87
Classification: Class III
Class II RecallOct 2025
Glenmark Pharmaceuticals Inc., USA
Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg, 3 Blister
Classification: Class II
Class II RecallOct 2025
Glenmark Pharmaceuticals Inc., USA
Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colval
Classification: Class II
Class II RecallAug 2025
Glenmark Pharmaceuticals Inc., USA
Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bard
Classification: Class II
Class II RecallAug 2025
Glenmark Pharmaceuticals Inc., USA
Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No
Classification: Class II
Class II RecallAug 2025
Glenmark Pharmaceuticals Inc., USA
Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot
Classification: Class II
Class II RecallAug 2025
Glenmark Pharmaceuticals Inc., USA
Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limite
Classification: Class II
Class II RecallAug 2025
Glenmark Pharmaceuticals Inc., USA
Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC 68462-162
Classification: Class II
Class II RecallAug 2025
Glenmark Pharmaceuticals Inc., USA
Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez
Classification: Class II
Class III RecallJun 2025
Glenmark Pharmaceuticals Inc., USA
Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd.,
Classification: Class III
Class II RecallJun 2025
Glenmark Pharmaceuticals Inc., USA
Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured f
Classification: Class II
Class II RecallJun 2025
Glenmark Pharmaceuticals Inc., USA
Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured
Classification: Class II
Class II RecallJun 2025
Glenmark Pharmaceuticals Inc., USA
Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark Ph
Classification: Class II
Class II RecallJun 2025
Glenmark Pharmaceuticals Inc., USA
Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05),
Classification: Class II
Class II RecallJun 2025
Glenmark Pharmaceuticals Inc., USA
Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx Only,
Classification: Class II
Class II RecallApr 2025
Glenmark Pharmaceuticals Inc., USA
Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Dis
Classification: Class II
Class II RecallApr 2025
Glenmark Pharmaceuticals Inc., USA
Ranolazine Extended-Release Tablets 1000mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limite
Classification: Class II
Class II RecallApr 2025
Glenmark Pharmaceuticals Inc., USA
Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b). 500-count bottle (NDC 16714-570-02), Rx On
Classification: Class II
Class II RecallApr 2025
Glenmark Pharmaceuticals Inc., USA
Fenofibrate Capsules 67 mg, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur
Classification: Class II
Class II RecallApr 2025
Glenmark Pharmaceuticals Inc., USA
Frovatriptan Succinate Tablets 2.5mg, 9-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pitham
Classification: Class II
Class II RecallApr 2025
Glenmark Pharmaceuticals Inc., USA
Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pith
Classification: Class II
Class II RecallApr 2025
Glenmark Pharmaceuticals Inc., USA
Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count bottle (NDC# 68462-196-90), Rx o
Classification: Class II
Class II RecallApr 2025
Glenmark Pharmaceuticals Inc., USA
Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle. Manufactured by: Glenmark Pharmaceuticals Limi
Classification: Class II
Class II RecallApr 2025
Glenmark Pharmaceuticals Inc., USA
Solifenacin Succinate Tablets 5mg, a.) 30-count bottle (NDC# 68462-386-30) b.) 90-count bottle (NDC# 68462-386-90), Rx O
Classification: Class II
Class II RecallApr 2025
Glenmark Pharmaceuticals Inc., USA
Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madh
Classification: Class II
Class II RecallApr 2025
Glenmark Pharmaceuticals Inc., USA
Prochlorperazine Maleate Tablets, 10mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, P
Classification: Class II
Class II RecallApr 2025
Glenmark Pharmaceuticals Inc., USA
Saxagliptin Tablets, USP, 2.5mg, a). 30-count bottle (NDC# 68462-726-30), b).90-count bottle(NDC# 68462-726-90), Manufac
Classification: Class II
Class II RecallApr 2025
Glenmark Pharmaceuticals Inc., USA
Lacosamide Tablets 150mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya
Classification: Class II
Class II RecallApr 2025
Glenmark Pharmaceuticals Inc., USA
Propafenone Hydrochloride Extended-Release Capsules 325mg, 60-count bottle, Rx Only Manufactured by: Glenmark Pharmaceut
Classification: Class II
Class II RecallApr 2025
Glenmark Pharmaceuticals Inc., USA
Voriconazole Tablets 50mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhy
Classification: Class II
Class II RecallApr 2025
Glenmark Pharmaceuticals Inc., USA
Colesvelam Hydrocholoride Tablets 625mg, 180-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, P
Classification: Class II
Class II RecallApr 2025
Glenmark Pharmaceuticals Inc., USA
Saxagliptin Tablets 5mg, a). 30-count bottle (NDC# 68462-727-30) b.) 90-count bottle ( 68462-727-90), Rx Only, Manufactu
Classification: Class II
Class II RecallApr 2025
Glenmark Pharmaceuticals Inc., USA
Nitroglycerin Sublingual Tablets 0.4MG 100-count carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pi
Classification: Class II
Class II RecallApr 2025
Glenmark Pharmaceuticals Inc., USA
Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count pack
Classification: Class II
Class II RecallApr 2025
Glenmark Pharmaceuticals Inc., USA
Lacosamide Tablets, 100mg , 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madh
Classification: Class II
Class II RecallApr 2025
Glenmark Pharmaceuticals Inc., USA
Pravastatin Sodium Tablets, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by
Classification: Class II
Class II RecallApr 2025
Glenmark Pharmaceuticals Inc., USA
Carvedilol Tablets, USP 12.5 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur
Classification: Class II
Class II RecallApr 2025
Glenmark Pharmaceuticals Inc., USA
Propafenone Hydrochloride Extended-Release Capsules USP, 225mg 60-count bottles, Rx Only, Mfd by: Glenmark Pharmaceutica
Classification: Class II
Class II RecallApr 2025
Glenmark Pharmaceuticals Inc., USA
Rufinamide Tablets 200mg, 120-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhy
Classification: Class II
Class II RecallApr 2025
Glenmark Pharmaceuticals Inc., USA
Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur,
Classification: Class II
Class II RecallApr 2025
Glenmark Pharmaceuticals Inc., USA
Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 100-count bottle, Rx, Only. Manufactured by: Glenmark Phar
Classification: Class II
Class II RecallApr 2025
Glenmark Pharmaceuticals Inc., USA
Lacosamide Tablets 200mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya
Classification: Class II
Class II RecallApr 2025
Glenmark Pharmaceuticals Inc., USA
Fluphenazine Hydrochloride Tablets, 10mg, 100-Count Bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited,
Classification: Class II
Class II RecallApr 2025
Glenmark Pharmaceuticals Inc., USA
Propafenone Hydrochloride Extended-Release Capsules, USP 325mg,60-count bottles, Rx Only, Mfd for: Northstar Rx LLC, Mem
Classification: Class II
Class II RecallApr 2025
Glenmark Pharmaceuticals Inc., USA
Rosuvastatin Tablets 40mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhy
Classification: Class II
Class II RecallApr 2025
Glenmark Pharmaceuticals Inc., USA
Indomethacin Extended-Release Capsules, 75mg, 60-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pitha
Classification: Class II
Class II RecallApr 2025
Glenmark Pharmaceuticals Inc., USA
Clindamycin Hydrochloride Capsules, USP, 300mg, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pi
Classification: Class II