{
  "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": "Canonsburg",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA076187"
        ],
        "brand_name": [
          "LEVOTHYROXINE SODIUM"
        ],
        "generic_name": [
          "LEVOTHYROXINE SODIUM"
        ],
        "manufacturer_name": [
          "Mylan Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "0378-1800",
          "0378-1803",
          "0378-1805",
          "0378-1807",
          "0378-1809",
          "0378-1811",
          "0378-1813",
          "0378-1823",
          "0378-1815",
          "0378-1817",
          "0378-1819",
          "0378-1821"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LEVOTHYROXINE SODIUM"
        ],
        "rxcui": [
          "892246",
          "892251",
          "892255",
          "966220",
          "966221",
          "966222",
          "966224",
          "966225",
          "966248",
          "966249",
          "966253",
          "966270"
        ],
        "spl_id": [
          "ca193039-55b1-4a7e-aa67-c4bff4f9f5b0"
        ],
        "spl_set_id": [
          "e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc"
        ],
        "package_ndc": [
          "0378-1800-77",
          "0378-1800-10",
          "0378-1803-77",
          "0378-1803-10",
          "0378-1805-77",
          "0378-1805-10",
          "0378-1807-77",
          "0378-1807-10",
          "0378-1809-77",
          "0378-1809-10",
          "0378-1811-77",
          "0378-1811-10",
          "0378-1813-77",
          "0378-1813-10",
          "0378-1823-77",
          "0378-1823-10",
          "0378-1815-77",
          "0378-1815-10",
          "0378-1817-77",
          "0378-1817-10",
          "0378-1819-77",
          "0378-1819-10",
          "0378-1821-77"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "9J765S329G"
        ]
      },
      "product_type": "Drugs",
      "event_id": "95768",
      "recalling_firm": "Viatris Inc",
      "address_1": "1000 Mylan Blvd",
      "address_2": "",
      "postal_code": "15317-5853",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States and Puerto Rico",
      "recall_number": "D-0121-2025",
      "product_description": "Levothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (NDC 0378-1817-77) and b) 1000-count bottles (NDC 0378-1817-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.",
      "product_quantity": "19, 549 bottles",
      "reason_for_recall": "Superpotent Drug and Subpotent Drug: potency failures obtained",
      "recall_initiation_date": "20241118",
      "center_classification_date": "20241212",
      "report_date": "20241218",
      "code_info": "Lot #: a) 3192915, 8172108, Exp. Date Mar 2025; b) 3208680, Exp. Date Sep 2025",
      "more_code_info": ""
    }
  ]
}