{
  "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": "Chantilly",
      "state": "VA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA218988"
        ],
        "brand_name": [
          "TRAZODONE HYDROCHLORIDE"
        ],
        "generic_name": [
          "TRAZODONE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Granules Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "70010-231",
          "70010-232",
          "70010-233",
          "70010-234"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TRAZODONE HYDROCHLORIDE"
        ],
        "rxcui": [
          "856364",
          "856369",
          "856373",
          "856377"
        ],
        "spl_id": [
          "562ce2d8-faa1-e856-e063-6294a90a3ebf"
        ],
        "spl_set_id": [
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        "package_ndc": [
          "70010-231-03",
          "70010-231-01",
          "70010-231-05",
          "70010-231-10",
          "70010-232-03",
          "70010-232-01",
          "70010-232-05",
          "70010-232-10",
          "70010-233-03",
          "70010-233-01",
          "70010-233-05",
          "70010-234-03",
          "70010-234-01",
          "70010-234-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0370010232013",
          "0370010233010",
          "0370010231016",
          "0370010234017"
        ],
        "unii": [
          "6E8ZO8LRNM"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98345",
      "recalling_firm": "Granules Pharmaceuticals Inc.",
      "address_1": "3701 Concorde Pkwy",
      "address_2": "N/A",
      "postal_code": "20151-1126",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "N/A",
      "distribution_pattern": "US Nationwide.",
      "recall_number": "D-0305-2026",
      "product_description": "Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-231-01.",
      "product_quantity": "71424 bottles.",
      "reason_for_recall": "Presence of Foreign Tablets/Capsules",
      "recall_initiation_date": "20260126",
      "center_classification_date": "20260211",
      "report_date": "20260211",
      "code_info": "Batch # 6160008A, Exp Date: 12/31/2026"
    }
  ]
}