{
  "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 III",
      "openfda": {
        "application_number": [
          "ANDA201567"
        ],
        "brand_name": [
          "BUPROPION"
        ],
        "generic_name": [
          "BUPROPION"
        ],
        "manufacturer_name": [
          "Zydus Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "68382-353",
          "68382-354"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "BUPROPION HYDROCHLORIDE"
        ],
        "rxcui": [
          "993541",
          "993557"
        ],
        "spl_id": [
          "00be046c-e051-4430-a967-3a0d4611da22"
        ],
        "spl_set_id": [
          "8d937ca3-3351-40f1-8192-348ba0c68162"
        ],
        "package_ndc": [
          "68382-354-06",
          "68382-354-16",
          "68382-354-05",
          "68382-354-10",
          "68382-353-06",
          "68382-353-16",
          "68382-353-05",
          "68382-353-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "ZG7E5POY8O"
        ]
      },
      "product_type": "Drugs",
      "event_id": "75764",
      "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": "Nationwide",
      "recall_number": "D-0207-2017",
      "product_description": "BuPROPion Hydrochloride Extended-Release Tablets (XL),  300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and  b) 500 count bottles (NDC 68382-354-05), Manufactured by: Cadila Healthcare LTD. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534",
      "product_quantity": "16,356 bottles",
      "reason_for_recall": "Failed Dissolution Specifications; 6 month time point",
      "recall_initiation_date": "20161102",
      "center_classification_date": "20161220",
      "termination_date": "20200723",
      "report_date": "20161228",
      "code_info": "a) MS1667 exp 01/2018; M601708, exp 03/2018;       b) MS1667, MS1668, MS1669, exp 01/2018; M601515, M601516, exp 03/2018; M602920, M602921, M605399, M602937, M602938, M602939, exp 04/2018; M603988, exp 06/2018"
    }
  ]
}