{"recall":{"id":"fda-drug-99563","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Zydus Pharmaceuticals (USA) Inc recalls Mirabegron Extended-Release Tablets","firm":"Zydus Pharmaceuticals (USA) Inc","date":"2026-08-05","reported":"2026-08-12","status":"Ongoing","classification":"Class II","products":[{"name":"Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1159-3.","code":"Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3","quantity":"","number":"D-0745-2026","classification":"Class II"}],"reason":"CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Nationwide in the USA","nationwide":true,"states":[],"units":"","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=99563","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"7ba22fb28daa4b95","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=99563","record":[{"status":"Ongoing","city":"Pennington","state":"NJ","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA209488"],"brand_name":["MIRABEGRON"],"generic_name":["MIRABEGRON"],"manufacturer_name":["Zydus Pharmaceuticals (USA) Inc."],"product_ndc":["70710-1159","70710-1160"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"substance_name":["MIRABEGRON"],"rxcui":["1300791","1300801"],"spl_id":["df34c0c9-8528-4fd6-a408-e1d44da0f156"],"spl_set_id":["2e40eb74-3b2a-47f7-bf31-fe27484f9bd2"],"package_ndc":["70710-1159-3","70710-1159-9","70710-1159-1","70710-1160-3","70710-1160-9","70710-1160-1"],"is_original_packager":[true],"nui":["N0000185008","N0000185007","N0000182137","N0000190114","N0000185503"],"pharm_class_epc":["beta3-Adrenergic Agonist [EPC]"],"pharm_class_moa":["Adrenergic beta3-Agonists [MoA]","Cytochrome P450 2D6 Inhibitors [MoA]","Cytochrome P450 3A Inhibitors [MoA]","P-Glycoprotein Inhibitors [MoA]"],"unii":["MVR3JL3B2V"]},"product_type":"Drugs","event_id":"99563","recalling_firm":"Zydus Pharmaceuticals (USA) Inc","address_1":"73 Route 31 N","address_2":"","postal_code":"08534-3601","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Nationwide in the USA","recall_number":"D-0745-2026","product_description":"Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1159-3.","product_quantity":"","reason_for_recall":"CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.","recall_initiation_date":"20260805","center_classification_date":"20260807","report_date":"20260812","code_info":"Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3","more_code_info":""}]}}