{"recall":{"id":"fda-drug-99767","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":"2026-08-31","reported":"2026-09-09","status":"Ongoing","classification":"Class III","products":[{"name":"Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 USA, NDC 17772-102-30.","code":"Lot# 2145283, Exp Date: 31-Mar-2030.","quantity":"11304 bottles","number":"D-0833-2026","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":"11304 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=99767","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"1f2da17487f85c98","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=99767","record":[{"status":"Ongoing","city":"Rockville","state":"MD","country":"United States","classification":"Class III","openfda":{},"product_type":"Drugs","event_id":"99767","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":"N/A","distribution_pattern":"US Nationwide.","recall_number":"D-0833-2026","product_description":"Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 USA, NDC 17772-102-30.","product_quantity":"11304 bottles","reason_for_recall":"Failed dissolution specifications.","recall_initiation_date":"20260831","center_classification_date":"20260903","report_date":"20260909","code_info":"Lot# 2145283, Exp Date: 31-Mar-2030.","more_code_info":""}]}}