Glenmark Pharmaceuticals recalls
FDA enforcement reports naming Glenmark Pharmaceuticals Inc., USA as the recalling firm.
- Recall reports
- 141
- Class I (serious)
- 2
- Most recent report
- Aug 5, 2026
- Aug 5, 2026Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Gl…Drug · Glenmark Pharmaceuticals Inc., USACGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.Class II
- Jun 24, 2026Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0Drug · Glenmark Pharmaceuticals Inc., USAFailed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.Class II
- Jan 7, 2026Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each co…Drug · Glenmark Pharmaceuticals Inc., USADefective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished prod…Class II
- Dec 17, 2025Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceutical…Drug · Glenmark Pharmaceuticals Inc., USACross Contamination with Other ProductsClass III
- Dec 10, 2025Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2Drug · Glenmark Pharmaceuticals Inc., USACross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibeClass III
- Oct 22, 2025Viorele, Desogestrel and Ethinyl Estradiol, USP, 0Drug · Glenmark Pharmaceuticals Inc., USAFailed Impurities/Degradation SpecificationsClass II
- Oct 1, 2025Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenma…Drug · Glenmark Pharmaceuticals Inc., USACGMP Deviations: Market complaints received for gritty texture (grainy)Class II
- Aug 20, 2025Carvedilol Tablets, USP, 12Drug · Glenmark Pharmaceuticals Inc., USACGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppmClass II
- Aug 20, 2025Carvedilol Tablets, USP, 3Drug · Glenmark Pharmaceuticals Inc., USACGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.Class II
- Aug 20, 2025Carvedilol Tablets, USP, 12Drug · Glenmark Pharmaceuticals Inc., USACGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.Class II
- Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by…
- Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenm…
- Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Ph…
- Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by…
- Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pha…
- Carvedilol Tablets USP 6
- Carvedilol Tablets USP 3
- Carvedilol Tablets USP 12
- Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx O…
- Colesvelam Hydrocholoride Tablets 625mg, 180-count bottle, Rx Only, Manufactured by: Gl…
- Prochlorperazine Maleate Tablets, 10mg, 100-count bottles, Rx Only, Manufactured by: Gl…
- Carvedilol Tablets, USP 12
- Ranolazine Extended-Release Tablets 1000mg, 60-count bottle, Rx Only, Manufactured by…
- Solifenacin Succinate Tablets 5mg, a
- Saxagliptin Tablets 5mg, a)
- Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle
- Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: Glenmark Ph…
- Nitroglycerin Sublingual Tablets 0
- Rufinamide Tablets 200mg, 120-count bottle, Rx Only, Manufactured by: Glenmark Pharmace…
- Frovatriptan Succinate Tablets 2
- Lacosamide Tablets 200mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceu…
- Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmac…
- Voriconazole Tablets 50mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmace…
- Propafenone Hydrochloride Extended-Release Capsules 325mg, 60-count bottle, Rx Only Man…
- Voriconazole Tablets 200 mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharma…
- Lacosamide Tablets, 100mg , 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmac…
- Fenofibrate Capsules 67 mg, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark P…
- Pravastatin Sodium Tablets, USP, 80mg, a)
- Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for…
- Propafenone Hydrochloride Extended-Release Capsules, USP 325mg,60-count bottles, Rx Onl…
- Fluphenazine Hydrochloride Tablets, 10mg, 100-Count Bottle, Rx Only, Manufactured by: G…
- Clindamycin Hydrochloride Capsules, USP, 300mg, 100-count bottles, Manufactured by: Gle…
- Rosuvastatin Tablets 40mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmace…
- Lacosamide Tablets, 50mg, 60-count bottles, Rx Only, Manufactured by: Glenmark Pharmace…
- Teriflunomide Tablets, 14mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharma…
- Propafenone Hydrochloride Extended-Release Capsules USP, 225mg 60-count bottles, Rx Onl…
- Pravastatin Sodium Tablets, USP, 20mg, a)
- Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a)
- Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by: Glenm…
- Saxagliptin Tablets, USP, 2
- Lacosamide Tablets 150mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceu…
- Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 100-count bottle, Rx, Only
- Pravastatin Sodium Tablets, 20mg, a)
- Fluphenazine Hydrochloride Tablets 2
- Nitroglycerin Sublingual Tablets 0
- Indomethacin Extended-Release Capsules, 75mg, 60-count bottles, Manufactured by: Glenma…
- Propafenone Hydrochloride Extended-Release Capsules 225mg, 60-count bottle, Rx Only, Ma…
- Solifenacin Succinate Tablets 10MG, a
- chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manu…
- Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenma…
- Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenma…
- Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenma…
- Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenma…
- Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenma…
- Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenma…
- Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenm…
- Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Norths…
- Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Norths…
- Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Norths…
- Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Norths…
- Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Norths…
- Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Norths…
- Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: North…
- Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets
- Carvedilol Tablets, USP, 12
- chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufacture…
- chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactur…
- Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx On…
- Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dosage, Rx On…
- Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, Twice-a-Day Dosage, Rx Onl…
- Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 Capsules, M…
- Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules, Ma…
- Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx On…
- Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665 mcg/25 mc…
- Ciclopirox Gel 0
- Mupirocin Ointment, USP, 2%, 22 g, Rx only, Manufactured by: Glenmark Pharmaceuticals, Ltd
- Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (ND…
- Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by: Glenmark Pharmace…
- Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle,…
- Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle,…
- Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle,…
- Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle
- Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle,…
- Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg, 18 (3 x 6) Unit-Dose Table…
- Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Dose Tabl…
- Rizatriptan Benzoate Tablets USP, 10 mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for…
- Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for:…
- Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100…
- Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100…
- Fluocinolone Acetonide Oil, 0
- Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharm…
- Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark P…
- Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle
- Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Manufactured…
- Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured…
- Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6
- Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-co…
- Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/25 mg, 30 Tablets, Rx Only, Manu…
- Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/12
- Tacrolimus Ointment, 0
- Aspirin and Extended-Release Dipyridamole Capsules, 25mg/200 mg, 60-count bottle, Rx On…
- Mometasone Furoate, Topical Solution USP, 0
- Desmopressin Acetate Tablets, 0
- Zonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manufactured by…
- Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01)
- Zonisamide Capsules, USP, 50 mg, packaged in 100-count bottles, Rx only, Manufactured b…
- Chlorzoxazone Tablets USP 375 mg 100 Tablets Rx Only NDC 68462-724-01 Manufactured by:…
- Naproxen Sodium Tablets, USP 275 mg 100 Tablets Rx Only NDC 68462-178-01 Manufactured b…
- Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 sing…
- Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC 68462-725-01 Manufactured by:…
- Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC 68462-129-01 Manufactured by: Gl…
- Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc
- Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc
- Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation Only Rx Only…
- Glenmark Ranitidine Tablets USP 150 mg Rx Only 500 Tablets Manufactured by: Glenmark Ph…
- Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets Manufactured by: Glenmark Ph…
- Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 Tablets Manufactured by: Glenmark Ph…
- Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pha…
- Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets Manufactured by: Glenmark Ph…
- Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Glenmark Pha…
- Clobetasol Propionate Foam, 0
- Clobetasol Propionate Foam (Emulsion Formulation), 0
- Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts (with dis…
- Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0
- Mometasone Furoate Cream USP, 0
- Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (with dispo…
- Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glen…
- Estradiol Vaginal Inserts, USP, 10 mcg, Rx only, packaged in a) 8 count (NDC 68462-711-…
- Aprepitant Capsules, USP 40 mg, 1 capsule Unit Blister Pack, Rx Only, Manufactured in…
- Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Glenmark…
- Glenmark Mometasone Furoate Cream, USP, 0
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