{
  "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": "Raleigh",
      "state": "NC",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA212399"
        ],
        "brand_name": [
          "LEVOTHYROXINE SODIUM"
        ],
        "generic_name": [
          "LEVOTHYROXINE SODIUM"
        ],
        "manufacturer_name": [
          "Accord Healthcare Inc."
        ],
        "product_ndc": [
          "16729-447",
          "16729-458",
          "16729-448",
          "16729-449",
          "16729-451",
          "16729-450",
          "16729-452",
          "16729-453",
          "16729-454",
          "16729-455",
          "16729-456",
          "16729-457"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LEVOTHYROXINE SODIUM"
        ],
        "rxcui": [
          "892246",
          "892251",
          "892255",
          "966220",
          "966221",
          "966222",
          "966224",
          "966225",
          "966248",
          "966249",
          "966253",
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        "spl_id": [
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        ],
        "spl_set_id": [
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        "package_ndc": [
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          "16729-451-17",
          "16729-450-15",
          "16729-450-17",
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          "16729-452-17",
          "16729-453-15",
          "16729-453-17",
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          "16729-454-17",
          "16729-455-15",
          "16729-455-17",
          "16729-456-15",
          "16729-456-17",
          "16729-457-15",
          "16729-457-17"
        ],
        "is_original_packager": [
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        "upc": [
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          "0316729452151",
          "0316729454155",
          "0316729453158",
          "0316729448154",
          "0316729451154",
          "0316729457156",
          "0316729450157",
          "0316729456159",
          "0316729458153",
          "0316729455152"
        ],
        "unii": [
          "9J765S329G"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99194",
      "recalling_firm": "ACCORD HEALTHCARE, INC.",
      "address_1": "8041 Arco Corporate Dr Ste 200",
      "address_2": "N/A",
      "postal_code": "27617-2010",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide.",
      "recall_number": "D-0656-2026",
      "product_description": "Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: lntas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-458-15.",
      "product_quantity": "6432 bottles",
      "reason_for_recall": "Subpotent Drug",
      "recall_initiation_date": "20260608",
      "center_classification_date": "20260630",
      "report_date": "20260708",
      "code_info": "Lot # D2401522, Exp Date: 06/2026."
    }
  ]
}