{
  "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"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0347335738865",
          "0347335737868"
        ],
        "unii": [
          "ZG7E5POY8O"
        ]
      },
      "product_type": "Drugs",
      "event_id": "76282",
      "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-0445-2017",
      "product_description": "buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (NDC 47335-737-86), b) 100 (NDC 47335-737-88)  and c) 500 (NDC 47335-737-13) count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India",
      "product_quantity": "a) 141,068 bottles b) 56,834 bottles c) 61,692 bottles",
      "reason_for_recall": "Failed Dissolution Specifications; 18 month stability time point",
      "recall_initiation_date": "20161220",
      "center_classification_date": "20170125",
      "termination_date": "20180711",
      "report_date": "20170201",
      "code_info": "a) 60 count JKP1184A , exp 2/17; JKP1576A, JKP2517A, JKP2527A, exp 04/17; JKP2768A exp 06/17; KP3895A, JKP4051A, exp 08/17; JKP4052A, JKP4605A exp 09/17       b) 100 count JKP0702A exp 01/17; JKP1186A exp 02/17; JKP2766A, exp 05/17; JKP3368A, JKP3369A exp 06/17; JKP3419A, JKP3420A exp 07/17; JKP4056A, JKP4603A, exp 09/17      c) 500 count JKP0093A, JKP0094A, JKP0703A, JKP0704A, exp 01/17; JKP1182A, JKP1183A, JKP1185A, exp 02/17; JKP1187A, JKP1188A, JKP1577A, JKP1578A, JKP2528A, exp 04/17; JKP2764A, JKP2765A, JKP2767A, exp 05/17; JKP3370A, JKP3371A, exp 06/17; JKP3372A, JKP3417A, JKP3418A, JKP3421A, JKP3889A, exp 07/17; JKP3892A, JKP3893A, JKP3894A, exp 08/17; JKP4053A, JKP4054A, JKP4055A, JKP4057A, JKP4600A, JKP4601A, JKP4602A, exp 09/17; JKP4742A, JKP4743A, exp 10/17"
    }
  ]
}