{
  "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": "Ongoing",
      "city": "Hyderabad",
      "state": "",
      "country": "India",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA211020"
        ],
        "brand_name": [
          "BUPROPION HYDROCHLORIDE"
        ],
        "generic_name": [
          "BUPROPION HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Rising Pharma Holdings, Inc."
        ],
        "product_ndc": [
          "16571-862",
          "16571-863"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "BUPROPION HYDROCHLORIDE"
        ],
        "rxcui": [
          "993541",
          "993557"
        ],
        "spl_id": [
          "fe42636a-ae04-43be-b032-8973bbdde7d5"
        ],
        "spl_set_id": [
          "e4f4d3fa-ddf6-4125-8486-8157efc095c1"
        ],
        "package_ndc": [
          "16571-862-03",
          "16571-862-09",
          "16571-862-50",
          "16571-862-10",
          "16571-862-12",
          "16571-863-03",
          "16571-863-09",
          "16571-863-50",
          "16571-863-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0316571862030",
          "0316571863037"
        ],
        "unii": [
          "ZG7E5POY8O"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97629",
      "recalling_firm": "Graviti Pharmaceuticals Private Limited",
      "address_1": "E & 621 Patancheru Mandal",
      "address_2": "Isnapur Village Rd; Survey No 621",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.",
      "recall_number": "D-0037-2026",
      "product_description": "Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limited, Sangareddy, Telangana, India, Dist. by: Rising Phar, NDC 16571-863-03.",
      "product_quantity": "46,512/30 count bottles",
      "reason_for_recall": "Failed Tablet/Capsule Specifications",
      "recall_initiation_date": "20250915",
      "center_classification_date": "20251021",
      "report_date": "20251029",
      "code_info": "Batch # BPB124341A, Exp date: 10/2026",
      "more_code_info": ""
    }
  ]
}