{
  "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": "Pennington",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA205253"
        ],
        "brand_name": [
          "TRAZODONE HYDROCHLORIDE"
        ],
        "generic_name": [
          "TRAZODONE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Zydus Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "68382-609",
          "68382-805",
          "68382-806",
          "68382-807",
          "68382-808",
          "68382-610"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TRAZODONE HYDROCHLORIDE"
        ],
        "rxcui": [
          "856364",
          "856369",
          "856373",
          "856377"
        ],
        "spl_id": [
          "24cb2e4c-a9ba-4283-8396-343f6aa03121"
        ],
        "spl_set_id": [
          "704aebf9-2fff-4ef3-8323-9ff0d7f0ffd9"
        ],
        "package_ndc": [
          "68382-805-01",
          "68382-805-30",
          "68382-805-77",
          "68382-805-05",
          "68382-805-10",
          "68382-805-06",
          "68382-805-16",
          "68382-806-06",
          "68382-806-16",
          "68382-806-01",
          "68382-806-05",
          "68382-806-10",
          "68382-806-30",
          "68382-806-77",
          "68382-807-06",
          "68382-807-16",
          "68382-807-01",
          "68382-807-05",
          "68382-807-10",
          "68382-807-30",
          "68382-807-77",
          "68382-808-06",
          "68382-808-16",
          "68382-808-01",
          "68382-808-05",
          "68382-808-10",
          "68382-808-30",
          "68382-808-77",
          "68382-609-01",
          "68382-609-05",
          "68382-609-10",
          "68382-610-01",
          "68382-610-05",
          "68382-610-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368382808011"
        ],
        "unii": [
          "6E8ZO8LRNM"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98184",
      "recalling_firm": "Zydus Pharmaceuticals (USA) Inc",
      "address_1": "73 Route 31 N",
      "address_2": "N/A",
      "postal_code": "08534-3601",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0247-2026",
      "product_description": "traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-806-10",
      "product_quantity": "2,136 1000-count bottles",
      "reason_for_recall": "Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.",
      "recall_initiation_date": "20251219",
      "center_classification_date": "20251231",
      "report_date": "20260107",
      "code_info": "Lot # EA00237A, Exp Date: 04/30/2027"
    }
  ]
}