{
  "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": [
          "ANDA040597"
        ],
        "brand_name": [
          "BENZONATATE"
        ],
        "generic_name": [
          "BENZONATATE"
        ],
        "manufacturer_name": [
          "Zydus Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "68382-091",
          "68382-247"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "BENZONATATE"
        ],
        "rxcui": [
          "197397",
          "283417"
        ],
        "spl_id": [
          "52dc3ff3-f01b-4820-ba1e-b043a5b2c49a"
        ],
        "spl_set_id": [
          "331c70dc-005e-4d96-a35c-4d2d810aa3b1"
        ],
        "package_ndc": [
          "68382-247-01",
          "68382-247-05",
          "68382-091-01"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000009010",
          "N0000175796"
        ],
        "pharm_class_pe": [
          "Decreased Tracheobronchial Stretch Receptor Activity [PE]"
        ],
        "pharm_class_epc": [
          "Non-narcotic Antitussive [EPC]"
        ],
        "unii": [
          "5P4DHS6ENR"
        ]
      },
      "product_type": "Drugs",
      "event_id": "70101",
      "recalling_firm": "Zydus Pharmaceuticals USA Inc",
      "address_1": "73 Route 31 N",
      "address_2": "",
      "postal_code": "08534-3601",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0325-2015",
      "product_description": "Benzonatate Capsules, USP, 100 mg,  Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA, In, Pennington, NJ USA 08534;  100-bottle capsules  - NDC 68382-247-01  500-bottle capsules - NDC 68382-247-05",
      "product_quantity": "19,536 units",
      "reason_for_recall": "Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.",
      "recall_initiation_date": "20141223",
      "center_classification_date": "20141223",
      "termination_date": "20170922",
      "report_date": "20141231",
      "code_info": "Lot #: MP2625, MP2626, MP2627 Exp 2/16; MP4875, MP4876, MP4877, MP4878  Exp 4/16; MP6482, MP6483, MP6484, MP6493, MP6494  Exp 6/16",
      "more_code_info": ""
    }
  ]
}