Glenmark Pharmaceuticals Inc., USA
Mahwah, NJ, United States
139
Total Recalls
2
Class I Recalls
109
Ongoing Recalls
Recalls by Glenmark Pharmaceuticals Inc., USA
FDA Drug
Class II
Ongoing
Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of
December 30, 2025
Glenmark Pharmaceuticals Inc., USA
96,948 packs units
FDA Drug
Class III
Ongoing
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-8
November 21, 2025
Glenmark Pharmaceuticals Inc., USA
11,136 bottles units
FDA Drug
Class III
Ongoing
Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for Avkare, Pulaski, TN 38478, Product of Italy,
November 18, 2025
Glenmark Pharmaceuticals Inc., USA
672 90-count bottles units
FDA Drug
Class II
Ongoing
Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., US
September 17, 2025
Glenmark Pharmaceuticals Inc., USA
13824 tubes units
FDA Drug
Class II
Ongoing
Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg, 3 Blisters each containing 28 Tablets, Rx only, 28 day Regimen, Manufactured by: Glenmark
September 3, 2025
Glenmark Pharmaceuticals Inc., USA
26,928 packs units
FDA Drug
Class II
Ongoing
Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa- 403513 India, Manufactured for: Glenmark Pharmaceuticals
August 8, 2025
Glenmark Pharmaceuticals Inc., USA
22,656 bottles units
FDA Drug
Class II
Ongoing
Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC 68462-162-01; Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa
August 7, 2025
Glenmark Pharmaceuticals Inc., USA
44,328 bottles units
FDA Drug
Class II
Ongoing
Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Ma
August 7, 2025
Glenmark Pharmaceuticals Inc., USA
6,432 bottles units
FDA Drug
Class II
Ongoing
Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahw
August 7, 2025
Glenmark Pharmaceuticals Inc., USA
4,800 bottles units
FDA Drug
Class II
Ongoing
Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775,
August 6, 2025
Glenmark Pharmaceuticals Inc., USA
17, 496 bottles units
FDA Drug
Class II
Ongoing
Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, In
August 6, 2025
Glenmark Pharmaceuticals Inc., USA
14,976 bottles units
FDA Drug
Class III
Ongoing
Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Madya Pradesh, India, Manufactured for: Gl
May 19, 2025
Glenmark Pharmaceuticals Inc., USA
6,759 Con - 90 bottle pack units
FDA Drug
Class II
Ongoing
Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited. Colvale-Bardez, Goa - 403513, India. Manufactured for: Gl
May 15, 2025
Glenmark Pharmaceuticals Inc., USA
8,520 100-count bottles units
FDA Drug
Class II
Ongoing
Nitroglycerin Sublingual Tablets 0.4MG 100-count carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceutical
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units
FDA Drug
Class II
Ongoing
Pravastatin Sodium Tablets, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units
FDA Drug
Class II
Ongoing
Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 100-count bottle, Rx, Only. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for:
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units
FDA Drug
Class II
Ongoing
Frovatriptan Succinate Tablets 2.5mg, 9-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals In
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units
FDA Drug
Class II
Ongoing
Lacosamide Tablets, 100mg , 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, M
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units
FDA Drug
Class II
Ongoing
Fluphenazine Hydrochloride Tablets, 10mg, 100-Count Bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceutic
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units
FDA Drug
Class II
Ongoing
Solifenacin Succinate Tablets 10MG, a. 30-count bottle (NDC# 68462-387-30), b. 90-Count Bottle (NDC 68462-387-90),Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units
FDA Drug
Class II
Ongoing
Voriconazole Tablets 50mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Ma
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units
FDA Drug
Class II
Ongoing
Rufinamide Tablets 200mg, 120-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Ma
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units
FDA Drug
Class II
Ongoing
Prochlorperazine Maleate Tablets, 10mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceutica
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units
FDA Drug
Class II
Ongoing
Propafenone Hydrochloride Extended-Release Capsules USP, 225mg 60-count bottles, Rx Only, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-825-01.
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units
FDA Drug
Class II
Ongoing
Propafenone Hydrochloride Extended-Release Capsules 225mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenm
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units
FDA Drug
Class II
Ongoing
Fenofibrate Capsules 67 mg, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc.
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units
FDA Drug
Class II
Ongoing
Nitroglycerin Sublingual Tablets 0.3MG, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. U
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units
FDA Drug
Class II
Ongoing
Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Distributed by: Amazon. NDC# 72657-129-35
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units
FDA Drug
Class II
Ongoing
Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units
FDA Drug
Class II
Ongoing
Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count bottle (NDC# 68462-196-90), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Prades
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units
FDA Drug
Class II
Ongoing
Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. U
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units
FDA Drug
Class II
Ongoing
Lacosamide Tablets, 50mg, 60-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Ma
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units
FDA Drug
Class II
Ongoing
Voriconazole Tablets 200 mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA,
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units
FDA Drug
Class II
Ongoing
Saxagliptin Tablets 5mg, a). 30-count bottle (NDC# 68462-727-30) b.) 90-count bottle ( 68462-727-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Indi
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units
FDA Drug
Class II
Ongoing
Indomethacin Extended-Release Capsules, 75mg, 60-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals I
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units
FDA Drug
Class II
Ongoing
Saxagliptin Tablets, USP, 2.5mg, a). 30-count bottle (NDC# 68462-726-30), b).90-count bottle(NDC# 68462-726-90), Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, In
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units
FDA Drug
Class II
Ongoing
Rosuvastatin Tablets 40mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Ma
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units
FDA Drug
Class II
Ongoing
Clindamycin Hydrochloride Capsules, USP, 300mg, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceutical
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units
FDA Drug
Class II
Ongoing
Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count packets( 72657-157-76),Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 0
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units
FDA Drug
Class II
Ongoing
Ranolazine Extended-Release Tablets 1000mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceu
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units
FDA Drug
Class II
Ongoing
Carvedilol Tablets, USP 12.5 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc.
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units
FDA Drug
Class II
Ongoing
Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, M
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units
FDA Drug
Class II
Ongoing
Lacosamide Tablets 150mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mah
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units
FDA Drug
Class II
Ongoing
Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmac
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units
FDA Drug
Class II
Ongoing
Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b). 500-count bottle (NDC 16714-570-02), Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceutica
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units
FDA Drug
Class II
Ongoing
Propafenone Hydrochloride Extended-Release Capsules, USP 325mg,60-count bottles, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Prad
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units
FDA Drug
Class II
Ongoing
Propafenone Hydrochloride Extended-Release Capsules 325mg, 60-count bottle, Rx Only Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenma
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units
FDA Drug
Class II
Ongoing
Colesvelam Hydrocholoride Tablets 625mg, 180-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceutica
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units
FDA Drug
Class II
Ongoing
Solifenacin Succinate Tablets 5mg, a.) 30-count bottle (NDC# 68462-386-30) b.) 90-count bottle (NDC# 68462-386-90), Rx Only. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Prades
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units
FDA Drug
Class II
Ongoing
Lacosamide Tablets 200mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mah
March 13, 2025
Glenmark Pharmaceuticals Inc., USA
N/A units