{
  "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": "97372",
      "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 within the USA",
      "recall_number": "D-0587-2025",
      "product_description": "Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India.  Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430, NDC 68462-164-05",
      "product_quantity": "17, 496 bottles",
      "reason_for_recall": "CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm",
      "recall_initiation_date": "20250806",
      "center_classification_date": "20250814",
      "report_date": "20250820",
      "code_info": "Lot #: 17241257, 17241258, 17241279, Exp. Date 06/2026",
      "more_code_info": ""
    }
  ]
}