{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Chantilly",
      "state": "VA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA216916"
        ],
        "brand_name": [
          "METOPROLOL SUCCINATE"
        ],
        "generic_name": [
          "METOPROLOL SUCCINATE"
        ],
        "manufacturer_name": [
          "Granules Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "70010-780",
          "70010-781",
          "70010-782",
          "70010-783"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "METOPROLOL SUCCINATE"
        ],
        "rxcui": [
          "866412",
          "866419",
          "866427",
          "866436"
        ],
        "spl_id": [
          "1c7ab139-2fb1-f011-e063-6394a90add6c"
        ],
        "spl_set_id": [
          "ff180ca2-7490-a571-e053-6394a90a97b1"
        ],
        "package_ndc": [
          "70010-780-01",
          "70010-780-05",
          "70010-780-10",
          "70010-781-01",
          "70010-781-05",
          "70010-781-10",
          "70010-782-01",
          "70010-782-05",
          "70010-782-10",
          "70010-783-01",
          "70010-783-05",
          "70010-783-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0370010782013",
          "0370010783010",
          "0370010781016"
        ],
        "unii": [
          "TH25PD4CCB"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97131",
      "recalling_firm": "Granules Pharmaceuticals Inc.",
      "address_1": "3701 Concorde Pkwy",
      "address_2": "",
      "postal_code": "20151-1126",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA.",
      "recall_number": "D-0510-2025",
      "product_description": "Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-count bottle, NDC 70010-780-05; Rx only, Manufactured by: Granules India Limited, Hyderadab-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151,",
      "product_quantity": "27,648 100-count Bottles; 5,376 500-count Bottles",
      "reason_for_recall": "Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.",
      "recall_initiation_date": "20250624",
      "center_classification_date": "20250708",
      "report_date": "20250709",
      "code_info": "Lot # a)1400008A, Exp Date: 12/31/2025; b) 1400008B, Exp Date: 12/31/2025",
      "more_code_info": ""
    }
  ]
}