{
  "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": "Terminated",
      "city": "Dublin",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA206073"
        ],
        "brand_name": [
          "GLYXAMBI"
        ],
        "generic_name": [
          "EMPAGLIFLOZIN AND LINAGLIPTIN"
        ],
        "manufacturer_name": [
          "Boehringer Ingelheim Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "0597-0164",
          "0597-0182"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "EMPAGLIFLOZIN",
          "LINAGLIPTIN"
        ],
        "rxcui": [
          "1602109",
          "1602115",
          "1602118",
          "1602120"
        ],
        "spl_id": [
          "16f275d5-7526-4e7a-8776-665a9a6ae37a"
        ],
        "spl_set_id": [
          "ddbab689-f76c-488c-9613-4168d41dd730"
        ],
        "package_ndc": [
          "0597-0182-70",
          "0597-0182-07",
          "0597-0182-03",
          "0597-0182-30",
          "0597-0182-39",
          "0597-0182-90",
          "0597-0164-30",
          "0597-0164-39",
          "0597-0164-90",
          "0597-0164-70",
          "0597-0164-07"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000187059",
          "N0000187058",
          "N0000175912",
          "N0000175913"
        ],
        "pharm_class_epc": [
          "Sodium-Glucose Cotransporter 2 Inhibitor [EPC]",
          "Dipeptidyl Peptidase 4 Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Sodium-Glucose Transporter 2 Inhibitors [MoA]",
          "Dipeptidyl Peptidase 4 Inhibitors [MoA]"
        ],
        "unii": [
          "HDC1R2M35U",
          "3X29ZEJ4R2"
        ]
      },
      "product_type": "Drugs",
      "event_id": "87512",
      "recalling_firm": "Cardinal Health Inc.",
      "address_1": "7000 Cardinal Pl",
      "address_2": "N/A",
      "postal_code": "43017-1091",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "FL, GA, SC",
      "recall_number": "D-0455-2021",
      "product_description": "Glyxambi (empagliflozin and linagliptin) Tablets 25 mg/5 mg 30 tablets Rx only NDC 0597-0164-30 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA",
      "product_quantity": "592 bottles",
      "reason_for_recall": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.",
      "recall_initiation_date": "20210315",
      "center_classification_date": "20210524",
      "termination_date": "20240617",
      "report_date": "20210602",
      "code_info": "3513"
    }
  ]
}