{
  "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": [
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          "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",
          "966270"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
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        "package_ndc": [
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          "16729-458-17",
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          "16729-447-17",
          "16729-448-15",
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          "16729-449-15",
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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",
          "16729-454-15",
          "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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          "0316729449151",
          "0316729452151",
          "0316729454155",
          "0316729453158",
          "0316729448154",
          "0316729451154",
          "0316729457156",
          "0316729450157",
          "0316729456159",
          "0316729458153",
          "0316729455152"
        ],
        "unii": [
          "9J765S329G"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97103",
      "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": "Nationwide in the USA",
      "recall_number": "D-0522-2025",
      "product_description": "Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-452-17",
      "product_quantity": "4,896 bottles",
      "reason_for_recall": "Subpotent Drug:  Assay below the approved specification",
      "recall_initiation_date": "20250620",
      "center_classification_date": "20250714",
      "report_date": "20250723",
      "code_info": "Lot #D2300104, Exp Date: 12/31/2025"
    }
  ]
}