{
  "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": "Terminated",
      "city": "Seymour",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA215802"
        ],
        "brand_name": [
          "LISDEXAMFETAMINE DIMESYLATE"
        ],
        "generic_name": [
          "LISDEXAMFETAMINE DIMESYLATE"
        ],
        "manufacturer_name": [
          "Lannett Company, Inc."
        ],
        "product_ndc": [
          "0527-4661",
          "0527-4662",
          "0527-4663",
          "0527-4664",
          "0527-4665",
          "0527-4666",
          "0527-4667"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LISDEXAMFETAMINE DIMESYLATE"
        ],
        "rxcui": [
          "854830",
          "854834",
          "854838",
          "854842",
          "854846",
          "854850",
          "1593856"
        ],
        "spl_id": [
          "cb49954d-0f9d-4471-bc86-0c926473c00b"
        ],
        "spl_set_id": [
          "2cedb4c2-1e40-4bc4-b9f4-127150c4afbd"
        ],
        "package_ndc": [
          "0527-4661-37",
          "0527-4662-37",
          "0527-4663-37",
          "0527-4664-37",
          "0527-4665-37",
          "0527-4666-37",
          "0527-4667-37"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0305274664379",
          "0305274666373",
          "0305274661378",
          "0305274665376",
          "0305274667370",
          "0305274663372"
        ],
        "unii": [
          "SJT761GEGS"
        ]
      },
      "product_type": "Drugs",
      "event_id": "95630",
      "recalling_firm": "Lannett Company Inc.",
      "address_1": "1101 C Ave W",
      "address_2": "",
      "postal_code": "47274-3342",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0112-2025",
      "product_description": "Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC:  0527-4661-37",
      "product_quantity": "1608 bottles",
      "reason_for_recall": "Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.",
      "recall_initiation_date": "20241025",
      "center_classification_date": "20241205",
      "termination_date": "20250627",
      "report_date": "20241211",
      "code_info": "Lot: 23274856A, Exp 04/30/2025",
      "more_code_info": ""
    }
  ]
}