{
  "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": "2026-09-02",
    "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",
          "966270"
        ],
        "spl_id": [
          "415fc774-31a5-124f-e063-6294a90a0e46"
        ],
        "spl_set_id": [
          "a6233381-3043-4e9a-aaa6-a6b105e5142b"
        ],
        "package_ndc": [
          "16729-458-15",
          "16729-458-17",
          "16729-447-15",
          "16729-447-17",
          "16729-448-15",
          "16729-448-17",
          "16729-449-15",
          "16729-449-17",
          "16729-451-15",
          "16729-451-17",
          "16729-450-15",
          "16729-450-17",
          "16729-452-15",
          "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": [
          true
        ],
        "upc": [
          "0316729447157",
          "0316729449151",
          "0316729452151",
          "0316729454155",
          "0316729453158",
          "0316729448154",
          "0316729451154",
          "0316729457156",
          "0316729450157",
          "0316729456159",
          "0316729458153",
          "0316729455152"
        ],
        "unii": [
          "9J765S329G"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99584",
      "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 within the United States",
      "recall_number": "D-0784-2026",
      "product_description": "Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-count bottles (NDC 16729-456-15), and b) 1000-count bottles (NDC 16729-456-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.",
      "product_quantity": "N/A",
      "reason_for_recall": "Subpotent Drug",
      "recall_initiation_date": "20260806",
      "center_classification_date": "20260821",
      "report_date": "20260902",
      "code_info": "a) Lot #: D2402642, Exp. Date 11/30/2026 b) Lot #: D2401832, Exp. Date 08/31/2026; D2402525, D2402527, D2402526, D2402644, D2402643, Exp. Date 11/30/2026."
    }
  ]
}