{
  "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": "2026-04-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Bridgewater",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA076003"
        ],
        "brand_name": [
          "TRAMADOL HYDROCHLORIDE"
        ],
        "generic_name": [
          "TRAMADOL HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Amneal Pharmaceuticals NY LLC"
        ],
        "product_ndc": [
          "60219-2348"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TRAMADOL HYDROCHLORIDE"
        ],
        "rxcui": [
          "835603"
        ],
        "spl_id": [
          "b19b19c4-cb47-4cbc-a914-dc73d4b655fa"
        ],
        "spl_set_id": [
          "8ec4e4e5-a56e-4198-8428-6b770b9bf27d"
        ],
        "package_ndc": [
          "60219-2348-4",
          "60219-2348-1",
          "60219-2348-5",
          "60219-2348-7"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "9N7R477WCK"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98623",
      "recalling_firm": "Amneal Pharmaceuticals, LLC",
      "address_1": "400 Crossing Blvd Fl 3",
      "address_2": "",
      "postal_code": "08807-2863",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "",
      "distribution_pattern": "Nationwide within the USA",
      "recall_number": "D-0408-2026",
      "product_description": "traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles,  Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India, Distributed by: Amneal Pharmaceuticals LLC, Glasgow, KY 42141, NDC 60219-2348-5.",
      "product_quantity": "29,542 bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).",
      "recall_initiation_date": "20260319",
      "center_classification_date": "20260330",
      "report_date": "20260408",
      "code_info": "Lot #: AM230987, Exp. Date 05/2026; AR232387, Exp. Date 12/2026.",
      "more_code_info": ""
    }
  ]
}