{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA214484"
        ],
        "brand_name": [
          "LISDEXAMFETAMINE DIMESYLATE"
        ],
        "generic_name": [
          "LISDEXAMFETAMINE DIMESYLATE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "57664-046",
          "57664-047",
          "57664-048",
          "57664-049",
          "57664-050",
          "57664-051",
          "57664-052",
          "57664-083",
          "57664-084",
          "57664-085",
          "57664-086",
          "57664-087",
          "57664-088"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LISDEXAMFETAMINE DIMESYLATE"
        ],
        "rxcui": [
          "854830",
          "854834",
          "854838",
          "854842",
          "854846",
          "854850",
          "1593856",
          "1871456",
          "1871460",
          "1871462",
          "1871464",
          "1871466",
          "1871468"
        ],
        "spl_id": [
          "0b77417a-5789-8818-e063-6294a90ad2e3"
        ],
        "spl_set_id": [
          "da3148af-f9b6-4725-adae-3595b4c7dc4b"
        ],
        "package_ndc": [
          "57664-047-88",
          "57664-046-88",
          "57664-048-88",
          "57664-049-88",
          "57664-050-88",
          "57664-051-88",
          "57664-052-88",
          "57664-083-88",
          "57664-084-88",
          "57664-085-88",
          "57664-086-88",
          "57664-087-88",
          "57664-088-88"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SJT761GEGS"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97092",
      "recalling_firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
      "address_1": "2 Independence Way",
      "address_2": "N/A",
      "postal_code": "08540-6620",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Recalled units were distributed to 17 distributors who may have further distributed the product nationwide.",
      "recall_number": "D-0516-2025",
      "product_description": "Lisdexamfetamine Dimesylate Capsules, 60 mg,\tCII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ 08512, NDC 57664-051-88",
      "product_quantity": "5,448 bottles",
      "reason_for_recall": "Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).",
      "recall_initiation_date": "20250616",
      "center_classification_date": "20250711",
      "report_date": "20250723",
      "code_info": "Lot # AD42648, Exp 02/28/2026"
    }
  ]
}