{
  "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": "Rockford",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA076187"
        ],
        "brand_name": [
          "LEVOTHYROXINE SODIUM"
        ],
        "generic_name": [
          "LEVOTHYROXINE SODIUM"
        ],
        "manufacturer_name": [
          "Mylan Institutional Inc."
        ],
        "product_ndc": [
          "51079-440",
          "51079-444",
          "51079-441",
          "51079-442",
          "51079-443",
          "51079-445"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LEVOTHYROXINE SODIUM"
        ],
        "rxcui": [
          "892246",
          "966220",
          "966221",
          "966222",
          "966224",
          "966225"
        ],
        "spl_id": [
          "3a864332-4c4d-08a5-e063-6294a90aaaff"
        ],
        "spl_set_id": [
          "5723c7a7-2a1d-4ab6-bf39-b2165ae781a6"
        ],
        "package_ndc": [
          "51079-440-01",
          "51079-440-20",
          "51079-444-01",
          "51079-444-20",
          "51079-441-01",
          "51079-441-20",
          "51079-442-01",
          "51079-442-20",
          "51079-443-01",
          "51079-443-20",
          "51079-445-01",
          "51079-445-20"
        ],
        "original_packager_product_ndc": [
          "0378-1803",
          "0378-1800",
          "0378-1805",
          "0378-1809",
          "0378-1813",
          "0378-1815"
        ],
        "unii": [
          "9J765S329G"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96428",
      "recalling_firm": "Mylan Institutional, Inc.",
      "address_1": "1718 Northrock Ct",
      "address_2": "N/A",
      "postal_code": "61103-1201",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0290-2025",
      "product_description": "Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-445-20.",
      "product_quantity": "347 Cartons",
      "reason_for_recall": "Super-Potent Drug: Out of specification potency results were obtained.",
      "recall_initiation_date": "20250307",
      "center_classification_date": "20250320",
      "report_date": "20250326",
      "code_info": "Lot 3116074, Exp. 09/30/2025"
    }
  ]
}