Recall archive
52 recalls · page 1 of 3
Reported Nov 4, 2026
Abiraterone Acetate Tablets USP 500 mg, 60-count bottles, Rx only, Distributed by: Glenmark Pharmaceuticals USA,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product · Product details — Labeling: Not Elsewhere Classified
FDA (weekly enforcement report)
Reported Oct 7, 2026
Clindamycin Phosphate Foam, 1%, FOR TOPICAL USE ONLY, Rx only, 100 g can, Manufactured for: Glenmark Pharmaceuticals,…
Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product · Product details — Defective Container: Firm received customer complaints of damaged and leaking product.
FDA (weekly enforcement report)
Reported Aug 5, 2026
Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc.,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product · Product details — CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
FDA (openFDA drug enforcement)
Reported Jun 24, 2026
Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product details — Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
FDA (openFDA drug enforcement)
Reported Jan 7, 2026
Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product details · Reason for recall — Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and…
FDA (openFDA drug enforcement)
Reported Dec 17, 2025
Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya…
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 — Cross Contamination with Other Products
FDA (openFDA drug enforcement)
Reported Dec 10, 2025
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product details — Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
FDA (openFDA drug enforcement)
Reported Oct 22, 2025
Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg, 3…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product details — Failed Impurities/Degradation Specifications
FDA (openFDA drug enforcement)
Reported Oct 1, 2025
Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product · Product details — CGMP Deviations: Market complaints received for gritty texture (grainy)
FDA (openFDA drug enforcement)
Reported Aug 20, 2025
Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product details — CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
5 more products in this recall
FDA (openFDA drug enforcement)
Reported Jun 18, 2025
Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd.,…
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 Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time…
FDA (openFDA drug enforcement)
Reported Jun 4, 2025
Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product details — CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
4 more products in this recall
FDA (openFDA drug enforcement)
Reported Apr 16, 2025
Fenofibrate Capsules 67 mg, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product · Product details — CGMP Deviations
38 more products in this recall
FDA (openFDA drug enforcement)
Reported Apr 9, 2025
chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark…
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 N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
FDA (openFDA drug enforcement)
Reported Feb 26, 2025
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ,…
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 N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
13 more products in this recall
FDA (openFDA drug enforcement)
Reported Feb 12, 2025
Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product details — CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Jan 1, 2025
chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: 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: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Dec 11, 2024
Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product details — cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
5 more products in this recall
FDA (openFDA drug enforcement)
Reported Oct 9, 2024
Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only, a) 30 gm Tube, NDC 68462-0455-35; b) 45…
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: Firm received complaints of broken tube at the seal.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Oct 2, 2024
Mupirocin Ointment, USP, 2%, 22 g, Rx only, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product · Product details — Subpotent Drug
FDA (openFDA drug enforcement)
Reported Sep 4, 2024
Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC 68462-325-60) and b) 90-count…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product details — Failed Dissolution Specifications: below specification results
FDA (openFDA drug enforcement)
Reported Aug 7, 2024
Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product · Product details — CGMP Deviations
FDA (openFDA drug enforcement)
Reported Jul 24, 2024
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by:…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product details — Failed Dissolution Specifications
4 more products in this recall
FDA (openFDA drug enforcement)
Reported Jun 12, 2024
Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc.,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Glenmark Pharmaceuticals Inc., USA
Matched: Brand · Product · Product details — CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
3 more products in this recall
FDA (openFDA drug enforcement)
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