{
  "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": "Cranbury",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA078866"
        ],
        "brand_name": [
          "BUPROPION HYDROCHLORIDE"
        ],
        "generic_name": [
          "BUPROPION HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "47335-736",
          "47335-737",
          "47335-738"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "BUPROPION HYDROCHLORIDE"
        ],
        "rxcui": [
          "993503",
          "993518",
          "993536"
        ],
        "spl_id": [
          "b8e6ae63-c5d7-4481-b7b0-17e135670515"
        ],
        "spl_set_id": [
          "29848192-7de3-4c0d-a822-1268dcf128b0"
        ],
        "package_ndc": [
          "47335-736-86",
          "47335-736-88",
          "47335-736-08",
          "47335-736-13",
          "47335-737-86",
          "47335-737-88",
          "47335-737-08",
          "47335-737-13",
          "47335-738-86",
          "47335-738-88",
          "47335-738-08",
          "47335-738-13",
          "3473357378"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0347335738865",
          "0347335737868",
          "347335737868"
        ],
        "unii": [
          "ZG7E5POY8O"
        ]
      },
      "product_type": "Drugs",
      "event_id": "75206",
      "recalling_firm": "Sun Pharmaceutical Industries, Inc.",
      "address_1": "270 Prospect Plains Rd",
      "address_2": "N/A",
      "postal_code": "08512-3605",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0007-2017",
      "product_description": "buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-Day, in 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by Sun Pharmaceuticals Ind. Ltd. Halol- Baroda Highway, Halol-389 350, Gujarat, India. UPC 347335737868  NDC 47335-737-86",
      "product_quantity": "31,762 bottles",
      "reason_for_recall": "Failed Dissolution Specifications",
      "recall_initiation_date": "20160913",
      "center_classification_date": "20161006",
      "termination_date": "20180702",
      "report_date": "20161012",
      "code_info": "JKN5124A and JKN5229A, exp 10/2016"
    }
  ]
}