Recall archive
50 recalls · page 2 of 3
Reported Jan 31, 2024
Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product details — Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
FDA (openFDA drug enforcement)
Reported Dec 6, 2023
Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product · Product details — Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Nov 29, 2023
Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b)…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product details — Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18…
FDA (openFDA drug enforcement)
Reported Nov 15, 2023
Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product · Product details — Failed Dissolution Specifications: Out of specification for dissolution.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Nov 8, 2023
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by:…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product details — Failed Impurities/Degradation Specifications
FDA (openFDA drug enforcement)
Reported Aug 30, 2023
Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product details — Subpotent: Out of Specification for Assay Test at the 3-month time point.
FDA (openFDA drug enforcement)
Reported Aug 17, 2022
Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/25 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product · Product details — Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the…
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Aug 10, 2022
Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product details — Defective Container: Tube split from side seam
FDA (openFDA drug enforcement)
Reported Jul 27, 2022
Aspirin and Extended-Release Dipyridamole Capsules, 25mg/200 mg, 60-count bottle, Rx Only, Manufactured for: Glenmark…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product · Product details — Failed Tablet/Capsule Specification : Capsule breakage
FDA (openFDA drug enforcement)
Reported Jul 13, 2022
Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC 68462-385-37), b) 60 ml-bottle (NDC…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product details — Defective Container
FDA (openFDA drug enforcement)
Reported Jul 6, 2022
Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product details — CGMP Deviations
FDA (openFDA drug enforcement)
Reported Jun 1, 2022
Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Direct Rx
Matched: Product details — CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
3 more products in this recall
FDA (openFDA drug enforcement)
Reported May 4, 2022
Zonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product · Product details — cGMP deviations
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Sep 29, 2021
Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Direct Rx
Matched: Product details — CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
FDA (openFDA drug enforcement)
Reported Sep 29, 2021
Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 single-dose pre-filled syringes Rx…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Glenmark Pharmaceuticals Inc., USA
Matched: Brand — Lack of Assurance of Sterility
7 more products in this recall
FDA (openFDA drug enforcement)
Reported Jan 15, 2020
Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product · Product details — CGMP Deviations: Presence of NDMA impurity detected in product.
5 more products in this recall
FDA (openFDA drug enforcement)
Reported Dec 18, 2019
Clobetasol Propionate Foam, 0.05%, a) 50 g pack (NDC 68462-608-27) and b) 100 g pack (NDC 68462-608-94), Rx only,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product details — Defective delivery system; product is not foaming or is coming out as liquid.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Nov 6, 2019
Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts (with disposable applicators) per carton…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product details — Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
FDA (openFDA drug enforcement)
Reported Aug 21, 2019
Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, 15 gram tubes, Rx only, Manufactured by: Glenmark…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product · Product details — Temperature Abuse: Complaints received of liquidy texture.
FDA (openFDA drug enforcement)
Reported Aug 14, 2019
Mometasone Furoate Cream USP, 0.1%, packaged in a) 15gram tubes (NDC 68462-192-17) and b) 45 gram tubes (NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product details · Reason for recall — GMP Deviations: Glenmark received complaints stating that mometasone fuorate cream was gritty.
FDA (openFDA drug enforcement)
Reported Jun 19, 2019
Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (with disposable applicators), Rx Only,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product details — Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.
FDA (openFDA drug enforcement)
Reported Apr 17, 2019
Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product · Product details — Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.
FDA (openFDA drug enforcement)
Reported Jan 16, 2019
Estradiol Vaginal Inserts, USP, 10 mcg, Rx only, packaged in a) 8 count (NDC 68462-711-71) and b) 18 count (NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product details — Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
FDA (openFDA drug enforcement)
Reported Dec 26, 2018
Aprepitant Capsules, USP 40 mg, 1 capsule Unit Blister Pack, Rx Only, Manufactured in India for: Glenmark…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product · Product details — Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack.
FDA (openFDA drug enforcement)
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