{"recall":{"id":"fda-drug-99375","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Supernus Pharmaceuticals, Inc. recalls Trokendi XR","firm":"Supernus Pharmaceuticals, Inc.","date":"2026-07-06","reported":"2026-07-29","status":"Ongoing","classification":"Class III","products":[{"name":"Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 USA, NDC 17772-101-30.","code":"Lot # 2075801, Exp Date: 31-Oct-2029.","quantity":"15,853 bottles","number":"D-0758-2026","classification":"Class III"}],"reason":"Failed Dissolution Specifications","hazard":"FDA Class III: not likely to cause adverse health consequences (FDA definition).","affected":"US Nationwide.","nationwide":true,"states":[],"units":"15,853 bottles","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=99375","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"02dc27941fe07abf","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=99375","record":[{"status":"Ongoing","city":"Rockville","state":"MD","country":"United States","classification":"Class III","openfda":{},"product_type":"Drugs","event_id":"99375","recalling_firm":"Supernus Pharmaceuticals, Inc.","address_1":"9715 Key West Ave","address_2":"N/A","postal_code":"20850-3900","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide.","recall_number":"D-0758-2026","product_description":"Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 USA, NDC 17772-101-30.","product_quantity":"15,853 bottles","reason_for_recall":"Failed Dissolution Specifications","recall_initiation_date":"20260706","center_classification_date":"20260811","report_date":"20260729","code_info":"Lot # 2075801, Exp Date: 31-Oct-2029."}]}}