{
  "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": "2026-09-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA074649"
        ],
        "brand_name": [
          "CARBAMAZEPINE"
        ],
        "generic_name": [
          "CARBAMAZEPINE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "51672-4005",
          "51672-4041",
          "51672-4050",
          "51672-4123",
          "51672-4124",
          "51672-4125",
          "51672-4047"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CARBAMAZEPINE"
        ],
        "rxcui": [
          "197442",
          "199378",
          "308973",
          "308976",
          "308979",
          "402505",
          "402506"
        ],
        "spl_id": [
          "48fd19fc-5d5b-0d24-e063-6294a90a0aa0"
        ],
        "spl_set_id": [
          "0526a054-3eda-49b4-b390-7d5d16e30af8"
        ],
        "package_ndc": [
          "51672-4041-1",
          "51672-4041-2",
          "51672-4041-9",
          "51672-4041-0",
          "51672-4050-1",
          "51672-4005-1",
          "51672-4005-2",
          "51672-4005-3",
          "51672-4123-6",
          "51672-4123-1",
          "51672-4123-3",
          "51672-4124-6",
          "51672-4124-1",
          "51672-4124-3",
          "51672-4125-6",
          "51672-4125-1",
          "51672-4125-3",
          "51672-4047-9",
          "51672-4047-4"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0351672405014",
          "0351672412418",
          "0351672404741"
        ],
        "nui": [
          "N0000008486",
          "N0000175751",
          "N0000185506",
          "N0000191266",
          "N0000187064",
          "N0000185507",
          "N0000185607"
        ],
        "pharm_class_pe": [
          "Decreased Central Nervous System Disorganized Electrical Activity [PE]"
        ],
        "pharm_class_epc": [
          "Mood Stabilizer [EPC]"
        ],
        "pharm_class_moa": [
          "Cytochrome P450 3A4 Inducers [MoA]",
          "Cytochrome P450 1A2 Inducers [MoA]",
          "Cytochrome P450 2B6 Inducers [MoA]",
          "Cytochrome P450 2C9 Inducers [MoA]",
          "Cytochrome P450 2C19 Inducers [MoA]"
        ],
        "unii": [
          "33CM23913M"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99562",
      "recalling_firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
      "address_1": "2 Independence Way",
      "address_2": "",
      "postal_code": "08540-6620",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide.",
      "recall_number": "D-0770-2026",
      "product_description": "Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC 51672-4005-3.",
      "product_quantity": "1968 Bottles (1000Tablets/Bottle)",
      "reason_for_recall": "CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing",
      "recall_initiation_date": "20260803",
      "center_classification_date": "20260818",
      "report_date": "20260826",
      "code_info": "Lot # AD94033, Exp Date: 5/31/2028.",
      "more_code_info": ""
    }
  ]
}