{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Dublin",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA209713"
        ],
        "brand_name": [
          "LEVOTHYROXINE SODIUM"
        ],
        "generic_name": [
          "LEVOTHYROXINE SODIUM"
        ],
        "manufacturer_name": [
          "Cardinal Health 107, LLC",
          "Major Pharmaceuticals"
        ],
        "product_ndc": [
          "55154-3558",
          "55154-3559",
          "55154-3560",
          "55154-4309",
          "55154-3561",
          "55154-3562",
          "55154-3563",
          "0904-6949",
          "0904-6950",
          "0904-6951",
          "0904-6952",
          "0904-6953",
          "0904-6954",
          "0904-6955",
          "0904-6956",
          "0904-6957"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LEVOTHYROXINE SODIUM"
        ],
        "rxcui": [
          "892246",
          "966220",
          "966221",
          "966222",
          "966224",
          "966225",
          "966253",
          "966248",
          "966249"
        ],
        "spl_id": [
          "1708f9ee-1578-432d-8d8c-e8192dd53b52",
          "942c00a3-b31c-48d5-a63d-6d394645ee1f"
        ],
        "spl_set_id": [
          "31a31756-68aa-4e01-bbb1-9d181f8d9181",
          "333642fd-93ae-4dc0-9c83-6d6b163c1c74"
        ],
        "package_ndc": [
          "55154-3558-0",
          "55154-3559-0",
          "55154-3560-0",
          "55154-4309-0",
          "55154-3561-0",
          "55154-3562-0",
          "55154-3563-0",
          "0904-6949-61",
          "0904-6950-61",
          "0904-6951-61",
          "0904-6952-61",
          "0904-6953-61",
          "0904-6954-61",
          "0904-6955-61",
          "0904-6956-61",
          "0904-6957-61"
        ],
        "original_packager_product_ndc": [
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          "0904-6951",
          "0904-6952",
          "0904-6953",
          "0904-6955",
          "0904-6956",
          "68180-965",
          "68180-966",
          "68180-967",
          "68180-968",
          "68180-969",
          "68180-970",
          "68180-971",
          "68180-973",
          "68180-974"
        ],
        "upc": [
          "0055154356305"
        ],
        "unii": [
          "9J765S329G"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99399",
      "recalling_firm": "Major Pharmaceuticals",
      "address_1": "7000 Cardinal Pl",
      "address_2": "N/A",
      "postal_code": "43017-1091",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA.",
      "recall_number": "D-0710-2026",
      "product_description": "Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3562-0; NDC Blister: 0904-6951-61",
      "product_quantity": "N/A",
      "reason_for_recall": "Subpotent Drug",
      "recall_initiation_date": "20260713",
      "center_classification_date": "20260717",
      "report_date": "20260729",
      "code_info": "Bag lot #: N02266A, N02266B, Exp. Date 11/2026; Blister lot #: N02266, Exp. Date 11/2026"
    }
  ]
}