{
  "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": "Ridgefield",
      "state": "CT",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA204629"
        ],
        "brand_name": [
          "JARDIANCE"
        ],
        "generic_name": [
          "EMPAGLIFLOZIN"
        ],
        "manufacturer_name": [
          "Boehringer Ingelheim Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "0597-0152",
          "0597-0153"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "EMPAGLIFLOZIN"
        ],
        "rxcui": [
          "1545658",
          "1545664",
          "1545666",
          "1545668"
        ],
        "spl_id": [
          "09daa78d-f417-436c-a29e-029c015ca6d6"
        ],
        "spl_set_id": [
          "faf3dd6a-9cd0-39c2-0d2e-232cb3f67565"
        ],
        "package_ndc": [
          "0597-0152-90",
          "0597-0152-07",
          "0597-0152-70",
          "0597-0152-37",
          "0597-0152-30",
          "0597-0153-37",
          "0597-0153-30",
          "0597-0153-90",
          "0597-0153-07",
          "0597-0153-70"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000187059",
          "N0000187058"
        ],
        "pharm_class_epc": [
          "Sodium-Glucose Cotransporter 2 Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Sodium-Glucose Transporter 2 Inhibitors [MoA]"
        ],
        "unii": [
          "HDC1R2M35U"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91879",
      "recalling_firm": "Boehringer Ingelheim Pharmaceuticals, Inc.",
      "address_1": "900 Ridgebury Rd",
      "address_2": "N/A",
      "postal_code": "06877-1058",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed nationwide within the United States and PR",
      "recall_number": "D-0468-2023",
      "product_description": "JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-0153-30) and b) 90-count (NDC 0597-0153-90) bottles, Rx only, Marketed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA and Eli Lilly and Company Indianapolis, IN 46285 USA",
      "product_quantity": "69,375 bottles",
      "reason_for_recall": "Labeling: Label Mix-up",
      "recall_initiation_date": "20230309",
      "center_classification_date": "20230317",
      "termination_date": "20231204",
      "report_date": "20230329",
      "code_info": "Lot #: a) and b) E61835, exp. date JUN 2025"
    }
  ]
}