Home / Brands / Glenmark Pharmaceuticals Inc., USA
Glenmark Pharmaceuticals Inc., USA Recalls
141 recalls on record · February 7, 2018 to August 5, 2026 · Drugs
Recalls by year
18
19
20
21
22
23
24
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 29, 2021DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Chlorzoxazone Tablets USP 375 mg 100 Tablets Rx Only NDC 68462-724-01 Manufactured by: Glenmark Pharmaceuticals Inc., U
Hazard: CGMP Deviations
September 29, 2021DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monro
Hazard: CGMP Deviations
September 29, 2021DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Naproxen Sodium Tablets, USP 275 mg 100 Tablets Rx Only NDC 68462-178-01 Manufactured by: Glenmark Pharmaceuticals Inc.,
Hazard: CGMP Deviations
September 29, 2021DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 single-dose pre-filled syringes Rx on
Hazard: Lack of Assurance of Sterility
January 15, 2020DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Glenmark Ranitidine Tablets USP 150 mg Rx Only 500 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
January 15, 2020DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
January 15, 2020DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
January 15, 2020DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez,
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
January 15, 2020DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
January 15, 2020DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez,
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
December 18, 2019DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Clobetasol Propionate Foam (Emulsion Formulation), 0.05% a) 50 g pack (NDC 68462-625-27) and b) 100 g pack (NDC 68462-62
Hazard: Defective delivery system; product is not foaming or is coming out as liquid.
December 18, 2019DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Clobetasol Propionate Foam, 0.05%, a) 50 g pack (NDC 68462-608-27) and b) 100 g pack (NDC 68462-608-94), Rx only, Manu
Hazard: Defective delivery system; product is not foaming or is coming out as liquid.
November 6, 2019DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts (with disposable applicators) per carton (
Hazard: Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
August 21, 2019DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, 15 gram tubes, Rx only, Manufactured by: Glenmark Pharm
Hazard: Temperature Abuse: Complaints received of liquidy texture.
August 14, 2019DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Mometasone Furoate Cream USP, 0.1%, packaged in a) 15gram tubes (NDC 68462-192-17) and b) 45 gram tubes (NDC 68462-192-5
Hazard: GMP Deviations: Glenmark received complaints stating that mometasone fuorate cream was gritty.
June 19, 2019DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (with disposable applicators), Rx Only, Manu
Hazard: Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.
April 17, 2019DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No
Hazard: Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.
January 16, 2019DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Estradiol Vaginal Inserts, USP, 10 mcg, Rx only, packaged in a) 8 count (NDC 68462-711-71) and b) 18 count (NDC 68462-71
Hazard: Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
December 26, 2018DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Aprepitant Capsules, USP 40 mg, 1 capsule Unit Blister Pack, Rx Only, Manufactured in India for: Glenmark Pharmaceutica
Hazard: Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack.
April 4, 2018DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bar
Hazard: Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One or two capsules 2 or 3 times a day." rather than the correct usual adult dosage of "One capsule 2 or 3 times a day.
February 7, 2018DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Glenmark Mometasone Furoate Cream, USP, 0.1%, 45 g Rx Only Manufactured by: Glenmark Pharmaceuticals Ltd. Village Manuf
Hazard: CGMP Deviations: Market complaints related to "gritty texture".