{
  "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": "2026-07-22",
    "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": "93166",
      "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-0044-2024",
      "product_description": "Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, 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, NDC 47335-737-86",
      "product_quantity": "144 bottles",
      "reason_for_recall": "Failed Dissolution Specifications",
      "recall_initiation_date": "20231004",
      "center_classification_date": "20231016",
      "termination_date": "20240202",
      "report_date": "20231025",
      "code_info": "Lot #: HAD0360A, Exp. 12/2023"
    }
  ]
}