{
  "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",
          "202517231315"
        ],
        "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": "96162",
      "recalling_firm": "Glenmark Pharmaceuticals Inc., USA",
      "address_1": "750 Corporate Dr",
      "address_2": "",
      "postal_code": "07430-2009",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the U.S",
      "recall_number": "D-0215-2025",
      "product_description": "Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured for Glenmark Pharmaceuticals, NJ.",
      "product_quantity": "",
      "reason_for_recall": "CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.",
      "recall_initiation_date": "20250122",
      "center_classification_date": "20250203",
      "report_date": "20250212",
      "code_info": "Lot numbers: a) 17230500, 17230509,17230526,17230546,17230551,17230603,17230628, 17230642,17230645,17230681, Exp.:02/2025; 17230829,17230832,17230854, 17230864,17230874,17230876,17230889,17230894, Exp.: 03/2025; 17230960, 17230964,17230976,17230981,17230985,17231161,17231171, Exp.: 04/2025 17231315,17231318,17231332,17231333,17231365, Exp.: 05/2025; 17231539, 17231563, Exp.: 06/2025; 17231653,17231662,17231663,17231680,17231691, 17231781,17231782,17231789, Exp.: 07/2025;17231838,17231880, Exp.: 08/2025; 17232144,17232147,17232151, Exp.: 09/2025; 17232369,17232370,17232408,17232409, 17232416,17232504,17232522,17232531,17232538,17232543, Exp.: 11/2025; 17240377,17240385,17240415,17240422,17240430,17240510, Exp.: 02/2026.  b) 17230551, 17240377, Exp.:02/2025",
      "more_code_info": ""
    }
  ]
}