{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Princeton",
      "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"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0347335738865",
          "0347335737868"
        ],
        "unii": [
          "ZG7E5POY8O"
        ]
      },
      "product_type": "Drugs",
      "event_id": "90088",
      "recalling_firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
      "address_1": "2 Independence Way",
      "address_2": "N/A",
      "postal_code": "08540-6620",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0857-2022",
      "product_description": "buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg packaged in a) 60-count bottle (47335-737-86), b)100-count bottle (47335-737-88), c)500-count bottle (47335-737-13), Rx only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India",
      "product_quantity": "9804 bottles",
      "reason_for_recall": "Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.",
      "recall_initiation_date": "20220429",
      "center_classification_date": "20220510",
      "termination_date": "20230925",
      "report_date": "20220518",
      "code_info": "Lot #: a) JKX5126A, JKX5127A, JKX5128A, Exp 10/2022; b) JKX5126B , JKX5128B, Exp 10/2022;  c)JKX5126C, JKX5127C, JKX5128C, Exp 10/2022;"
    }
  ]
}