{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-19",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Rockville",
      "state": "MD",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA201635"
        ],
        "brand_name": [
          "TROKENDI XR"
        ],
        "generic_name": [
          "TOPIRAMATE"
        ],
        "manufacturer_name": [
          "Supernus Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "17772-101",
          "17772-102",
          "17772-103",
          "17772-104"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TOPIRAMATE"
        ],
        "rxcui": [
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          "1436245",
          "1437278",
          "1437280",
          "1437283",
          "1437285",
          "1437288",
          "1437290"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
          "2dc7957e-a3e5-46bb-aa66-f3250f872f5e"
        ],
        "package_ndc": [
          "17772-102-70",
          "17772-102-01",
          "17772-102-30",
          "17772-102-15",
          "17772-102-10",
          "17772-102-12",
          "17772-102-07",
          "17772-103-70",
          "17772-103-01",
          "17772-103-30",
          "17772-103-15",
          "17772-103-10",
          "17772-103-12",
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          "17772-104-01",
          "17772-104-30",
          "17772-104-15",
          "17772-104-12",
          "17772-104-10",
          "17772-104-07",
          "17772-101-70",
          "17772-101-01",
          "17772-101-30",
          "17772-101-15",
          "17772-101-10",
          "17772-101-12",
          "17772-101-07"
        ],
        "is_original_packager": [
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        ],
        "upc": [
          "0317772101300",
          "0317772102307",
          "0317772104301",
          "0317772103304"
        ],
        "nui": [
          "N0000008486",
          "N0000185506",
          "N0000182140"
        ],
        "pharm_class_pe": [
          "Decreased Central Nervous System Disorganized Electrical Activity [PE]"
        ],
        "pharm_class_moa": [
          "Cytochrome P450 3A4 Inducers [MoA]",
          "Cytochrome P450 2C19 Inhibitors [MoA]"
        ],
        "unii": [
          "0H73WJJ391"
        ]
      },
      "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."
    }
  ]
}