{
  "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": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA078251"
        ],
        "brand_name": [
          "CARVEDILOL"
        ],
        "generic_name": [
          "CARVEDILOL"
        ],
        "manufacturer_name": [
          "Glenmark Pharmaceuticals Inc., USA"
        ],
        "product_ndc": [
          "68462-162",
          "68462-163",
          "68462-164",
          "68462-165"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CARVEDILOL"
        ],
        "rxcui": [
          "200031",
          "200032",
          "200033",
          "686924"
        ],
        "spl_id": [
          "5f5b2d20-cc2a-4e91-b2b9-260e7438ab2c"
        ],
        "spl_set_id": [
          "c4a21f67-7812-4634-beba-f8e85c63c5f2"
        ],
        "package_ndc": [
          "68462-162-60",
          "68462-162-01",
          "68462-162-18",
          "68462-162-05",
          "68462-162-10",
          "68462-163-60",
          "68462-163-01",
          "68462-163-18",
          "68462-163-05",
          "68462-163-10",
          "68462-164-60",
          "68462-164-01",
          "68462-164-18",
          "68462-164-05",
          "68462-164-10",
          "68462-165-60",
          "68462-165-01",
          "68462-165-18",
          "68462-165-05",
          "68462-165-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368462162019",
          "0368462163016",
          "0368462164013",
          "0368462165010"
        ],
        "nui": [
          "N0000000099",
          "N0000009923",
          "N0000009924",
          "N0000175553",
          "N0000175556"
        ],
        "pharm_class_moa": [
          "Adrenergic alpha-Antagonists [MoA]",
          "Adrenergic beta1-Antagonists [MoA]",
          "Adrenergic beta2-Antagonists [MoA]"
        ],
        "pharm_class_epc": [
          "alpha-Adrenergic Blocker [EPC]",
          "beta-Adrenergic Blocker [EPC]"
        ],
        "unii": [
          "0K47UL67F2"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97370",
      "recalling_firm": "Glenmark Pharmaceuticals Inc., USA",
      "address_1": "750 Corporate Dr",
      "address_2": "N/A",
      "postal_code": "07430-2009",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0578-2025",
      "product_description": "Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC 68462-164-05",
      "product_quantity": "6,432 bottles",
      "reason_for_recall": "CGMP Deviations: Presence of a nitrosamine,  N-Nitroso Carvedilol I  Impurity above the current Acceptable Intake Level.",
      "recall_initiation_date": "20250807",
      "center_classification_date": "20250812",
      "report_date": "20250820",
      "code_info": "Lot#:19243202, Exp: 7/31/2026.",
      "more_code_info": ""
    }
  ]
}