{
  "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": "96474",
      "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": "U.S. Nationwide",
      "recall_number": "D-0336-2025",
      "product_description": "Carvedilol Tablets, USP 12.5 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430 NDC# 68462-164-05.",
      "product_quantity": "N/A",
      "reason_for_recall": "CGMP Deviations",
      "recall_initiation_date": "20250313",
      "center_classification_date": "20250408",
      "report_date": "20250416",
      "code_info": "Lot #  17240238, exp. date  Jan-26  17240243, exp. date  Jan-26 17240245, exp. date  Jan-26  17240248, exp. date  Jan-26"
    }
  ]
}