DrugSep 29, 2021
Naproxen Sodium Tablets, USP 550 mg recall — FDA D-0822-2021
CGMP Deviations
Class IIFDA: TerminatedGlenmark Pharmaceuticals Inc., USA
Recall history in this database
Classification mix: Class II: 47, Class III: 12, Class I: 2.
DrugSep 29, 2021
Glenmark Pharmaceuticals Inc., USA Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL recall — FDA D-0827-2021
Lack of Assurance of Sterility
Class IIFDA: TerminatedGlenmark Pharmaceuticals Inc., USA
DrugDec 18, 2019
Clobetasol Propionate Foam, 0.05%, a) 50 g pack (NDC 68462-608-27) and b) 100 g pack recall — FDA D-0618-2020
Defective delivery system; product is not foaming or is coming out as liquid.
Class IIIFDA: TerminatedGlenmark Pharmaceuticals Inc., USA
DrugDec 18, 2019
Clobetasol Propionate Foam (Emulsion Formulation), 0.05% a) 50 g pack (NDC 68462-625-27) and recall — FDA D-0619-2020
Defective delivery system; product is not foaming or is coming out as liquid.
Class IIIFDA: TerminatedGlenmark Pharmaceuticals Inc., USA
DrugNov 6, 2019
Estradiol Vaginal Inserts USP, 10 mcg recall — FDA D-0156-2020
Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
Class IIFDA: TerminatedGlenmark Pharmaceuticals Inc., USA
DrugAug 21, 2019
Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, 15 gram tubes recall — FDA D-1743-2019
Temperature Abuse: Complaints received of liquidy texture.
Class IIIFDA: TerminatedGlenmark Pharmaceuticals Inc., USA
DrugAug 14, 2019
Mometasone Furoate Cream USP, 0.1% recall — FDA D-1586-2019
GMP Deviations: Glenmark received complaints stating that mometasone fuorate cream was gritty.
Class IIFDA: TerminatedGlenmark Pharmaceuticals Inc., USA
DrugJun 19, 2019
Estradiol Vaginal Inserts USP 10 mcg recall — FDA D-1340-2019
Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.
Class IIFDA: TerminatedGlenmark Pharmaceuticals Inc., USA
DrugApr 17, 2019
Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle recall — FDA D-1120-2019
Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.
Class IIFDA: TerminatedGlenmark Pharmaceuticals Inc., USA
DrugJan 16, 2019
Estradiol Vaginal Inserts, USP, 10 mcg recall — FDA D-0350-2019
Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
Class IIFDA: TerminatedGlenmark Pharmaceuticals Inc., USA
DrugDec 26, 2018
Aprepitant Capsules, USP 40 mg, 1 capsule Unit Blister Pack recall — FDA D-0349-2019
Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack.
Class IIIFDA: TerminatedGlenmark Pharmaceuticals Inc., USA
DrugApr 4, 2018
Indomethacin Capsules USP, 50 mg, 100-count bottle recall — FDA D-0606-2018
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…
Class IIIFDA: TerminatedGlenmark Pharmaceuticals Inc., USA
DrugFeb 7, 2018
Glenmark Mometasone Furoate Cream, USP, 0.1%, 45 g recall — FDA D-0336-2018
CGMP Deviations: Market complaints related to "gritty texture".
Class IIFDA: TerminatedGlenmark Pharmaceuticals Inc., USA
Understanding this recall history
This page summarizes recall records in which the official source identifies Glenmark Pharmaceuticals Inc., USA as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.