Recall archive
52 recalls · page 2 of 3
Reported May 1, 2024
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product details — Failed Dissolution Specifications
FDA (openFDA drug enforcement)
Reported Apr 10, 2024
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product details — Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability…
FDA (openFDA drug enforcement)
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)
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