{"recall":{"id":"fda-drug-99490","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Glenmark Pharmaceuticals Inc., USA recalls Azelaic Acid Gel","firm":"Glenmark Pharmaceuticals Inc., USA","date":"2026-07-23","reported":"2026-08-05","status":"Ongoing","classification":"Class II","products":[{"name":"Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52.","code":"Lot #: 19260937A, Exp. Date February 2028; 19261225A, 19261185A, Exp. Date March 2028; 19261664A, 19261682A, Exp. Date April 2028.","quantity":"N/A","number":"D-0731-2026","classification":"Class II"}],"reason":"CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Nationwide within the United States.","nationwide":true,"states":[],"units":"N/A","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99490","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"83dd73ee9b068f73","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99490","record":[{"status":"Ongoing","city":"Elmwood Park","state":"NJ","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA204637"],"brand_name":["AZELAIC ACID"],"generic_name":["AZELAIC ACID"],"manufacturer_name":["Glenmark Pharmaceuticals Inc., USA"],"product_ndc":["68462-626"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["TOPICAL"],"substance_name":["AZELAIC ACID"],"rxcui":["1041518"],"spl_id":["28cca0c1-2f38-4fa2-8aaf-d3c8978b0fc6"],"spl_set_id":["0b5ab22e-c78a-4429-9a76-a4ba2d11fcde"],"package_ndc":["68462-626-52"],"is_original_packager":[true],"upc":["0368462626528"],"nui":["N0000008841","N0000009982"],"pharm_class_pe":["Decreased Protein Synthesis [PE]","Decreased Sebaceous Gland Activity [PE]"],"unii":["F2VW3D43YT"]},"product_type":"Drugs","event_id":"99490","recalling_firm":"Glenmark Pharmaceuticals Inc., USA","address_1":"619 River Dr","address_2":"N/A","postal_code":"07407-1317","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distribution_pattern":"Nationwide within the United States.","recall_number":"D-0731-2026","product_description":"Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52.","product_quantity":"N/A","reason_for_recall":"CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.","recall_initiation_date":"20260723","center_classification_date":"20260728","report_date":"20260805","code_info":"Lot #: 19260937A, Exp. Date February 2028; 19261225A, 19261185A, Exp. Date March 2028; 19261664A, 19261682A, Exp. Date April 2028."}]}}