{
  "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": "Terminated",
      "city": "Morristown",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA021116"
        ],
        "brand_name": [
          "LEVOTHYROXINE SODIUM"
        ],
        "generic_name": [
          "LEVOTHYROXINE SODIUM"
        ],
        "manufacturer_name": [
          "Alvogen, Inc."
        ],
        "product_ndc": [
          "47781-640",
          "47781-643",
          "47781-646",
          "47781-649",
          "47781-651",
          "47781-654",
          "47781-657",
          "47781-659",
          "47781-662",
          "47781-665",
          "47781-668",
          "47781-671"
        ],
        "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": [
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        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
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          "47781-640-10",
          "47781-643-90",
          "47781-643-10",
          "47781-646-90",
          "47781-646-10",
          "47781-649-90",
          "47781-649-10",
          "47781-651-90",
          "47781-651-10",
          "47781-654-90",
          "47781-654-10",
          "47781-657-90",
          "47781-657-10",
          "47781-659-90",
          "47781-659-10",
          "47781-662-90",
          "47781-662-10",
          "47781-665-90",
          "47781-665-10",
          "47781-668-90",
          "47781-668-10",
          "47781-671-90",
          "47781-671-10"
        ],
        "is_original_packager": [
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        ],
        "upc": [
          "0347781649906",
          "0347781671907",
          "0347781643904",
          "0347781657901",
          "0347781640903",
          "0347781651909",
          "0347781662905",
          "0347781665906",
          "0347781646905",
          "0347781654900",
          "0347781659905"
        ],
        "unii": [
          "9J765S329G"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91654",
      "recalling_firm": "Alvogen, Inc",
      "address_1": "44 Whippany Rd Ste 107",
      "address_2": "N/A",
      "postal_code": "07960-4558",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Puerto Rico.",
      "recall_number": "D-0353-2023",
      "product_description": "Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manufactured by Lloyd Inc., Shenandoah, IA, 51601, Distributed by: Alvogen Inc, Pine Brook, NJ 07058, NDC 47781-654-90.",
      "product_quantity": "21,276 bottles",
      "reason_for_recall": "Sub-Potent Drug: Out of specification for assay at the 24 month interval.",
      "recall_initiation_date": "20230206",
      "center_classification_date": "20230224",
      "termination_date": "20240318",
      "report_date": "20230308",
      "code_info": "Lot # HE02221, Exp. 05/2023",
      "more_code_info": ""
    }
  ]
}