{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Pennington",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA078235"
        ],
        "brand_name": [
          "TOPIRAMATE"
        ],
        "generic_name": [
          "TOPIRAMATE"
        ],
        "manufacturer_name": [
          "Zydus Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "68382-138",
          "68382-139",
          "68382-140",
          "68382-141"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TOPIRAMATE"
        ],
        "rxcui": [
          "151226",
          "199888",
          "199889",
          "199890"
        ],
        "spl_id": [
          "970d3fcf-0744-47c3-8a88-706956e9ea21"
        ],
        "spl_set_id": [
          "67dcdd6e-48bc-418e-a887-805929d83ce0"
        ],
        "package_ndc": [
          "68382-138-14",
          "68382-138-16",
          "68382-138-01",
          "68382-138-05",
          "68382-139-14",
          "68382-139-16",
          "68382-139-01",
          "68382-139-05",
          "68382-140-14",
          "68382-140-16",
          "68382-140-01",
          "68382-140-05",
          "68382-141-14",
          "68382-141-16",
          "68382-141-01",
          "68382-141-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368382139146",
          "0368382141149",
          "0368382138149",
          "0368382140142"
        ],
        "nui": [
          "N0000008486",
          "N0000185506",
          "N0000182140"
        ],
        "pharm_class_pe": [
          "Decreased Central Nervous System Disorganized Electrical Activity [PE]"
        ],
        "pharm_class_moa": [
          "Cytochrome P450 3A4 Inducers [MoA]",
          "Cytochrome P450 2C19 Inhibitors [MoA]"
        ],
        "unii": [
          "0H73WJJ391"
        ]
      },
      "product_type": "Drugs",
      "event_id": "69387",
      "recalling_firm": "Zydus Pharmaceuticals USA Inc",
      "address_1": "73 Route 31 N",
      "address_2": "N/A",
      "postal_code": "08534-3601",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide",
      "recall_number": "D-0015-2015",
      "product_description": "TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ USA 08534. NDC 68382-141-14.",
      "product_quantity": "14,568 Bottles",
      "reason_for_recall": "Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.",
      "recall_initiation_date": "20140915",
      "center_classification_date": "20141010",
      "termination_date": "20170920",
      "report_date": "20141022",
      "code_info": "Lot #: MN9828, Expiry: Oct 2015."
    }
  ]
}