{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Miami",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA215401"
        ],
        "brand_name": [
          "XELSTRYM"
        ],
        "generic_name": [
          "DEXTROAMPHETAMINE"
        ],
        "manufacturer_name": [
          "Noven Therapeutics, LLC"
        ],
        "product_ndc": [
          "68968-0205",
          "68968-0210",
          "68968-0215",
          "68968-0220"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TRANSDERMAL"
        ],
        "substance_name": [
          "DEXTROAMPHETAMINE"
        ],
        "rxcui": [
          "2624701",
          "2624708",
          "2624712",
          "2624715",
          "2624726",
          "2624729",
          "2624732",
          "2624735"
        ],
        "spl_id": [
          "11163145-d173-4320-aac9-92069f0cbf4a"
        ],
        "spl_set_id": [
          "0862f02a-72a8-41cc-8845-57cf4974bb6f"
        ],
        "package_ndc": [
          "68968-0205-1",
          "68968-0205-3",
          "68968-0210-1",
          "68968-0210-3",
          "68968-0215-1",
          "68968-0215-3",
          "68968-0220-1",
          "68968-0220-3"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175739",
          "N0000175729"
        ],
        "pharm_class_epc": [
          "Central Nervous System Stimulant [EPC]"
        ],
        "pharm_class_pe": [
          "Central Nervous System Stimulation [PE]"
        ],
        "unii": [
          "TZ47U051FI"
        ]
      },
      "product_type": "Drugs",
      "event_id": "95701",
      "recalling_firm": "Noven Pharmaceuticals Inc",
      "address_1": "11960 Sw 144th St",
      "address_2": "N/A",
      "postal_code": "33186-6109",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA nationwide.",
      "recall_number": "D-0055-2025",
      "product_description": "Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal patches, inside a foil-sealed polypropylene tray, packed in a paper carton/box, MANUFACTURED BY NOVEN PHARMACEUTICALS, INC., Miami, FL 33186 United Sates, NDC 68968-0215-3",
      "product_quantity": "685 boxes",
      "reason_for_recall": "Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).",
      "recall_initiation_date": "20241031",
      "center_classification_date": "20241119",
      "report_date": "20241127",
      "code_info": "Lot # 95598, Exp 02/28/25"
    }
  ]
}