{
  "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": "Ongoing",
      "city": "Mumbai",
      "state": "",
      "country": "India",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA211417"
        ],
        "brand_name": [
          "LEVOTHYROXINE SODIUM"
        ],
        "generic_name": [
          "LEVOTHYROXINE SODIUM"
        ],
        "manufacturer_name": [
          "Macleods Pharmaceuticals Limited"
        ],
        "product_ndc": [
          "33342-393",
          "33342-394",
          "33342-395",
          "33342-396",
          "33342-397",
          "33342-398",
          "33342-399",
          "33342-400",
          "33342-401",
          "33342-402",
          "33342-403",
          "33342-404"
        ],
        "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": [
          "3a77ca51-7d8a-4755-aabc-3801cc772a10"
        ],
        "spl_set_id": [
          "b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9"
        ],
        "package_ndc": [
          "33342-393-10",
          "33342-393-11",
          "33342-393-44",
          "33342-394-10",
          "33342-394-11",
          "33342-394-44",
          "33342-395-10",
          "33342-395-11",
          "33342-395-44",
          "33342-396-10",
          "33342-396-11",
          "33342-396-44",
          "33342-397-10",
          "33342-397-11",
          "33342-397-44",
          "33342-398-10",
          "33342-398-11",
          "33342-398-44",
          "33342-399-10",
          "33342-399-11",
          "33342-399-44",
          "33342-400-10",
          "33342-400-11",
          "33342-400-44",
          "33342-401-10",
          "33342-401-11",
          "33342-401-44",
          "33342-402-10",
          "33342-402-11",
          "33342-402-44",
          "33342-403-10",
          "33342-403-11",
          "33342-403-44",
          "33342-404-10",
          "33342-404-11",
          "33342-404-44"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0333342393104",
          "0333342397102",
          "0333342404107",
          "0333342393111",
          "0333342400109",
          "0333342403100",
          "0333342393449",
          "0333342394101",
          "0333342402103",
          "0333342396105",
          "0333342395108",
          "0333342398109",
          "0333342399106"
        ],
        "unii": [
          "9J765S329G"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96979",
      "recalling_firm": "Macleods Pharmaceuticals Ltd",
      "address_1": "304 Atlanta Arcade",
      "address_2": "Church Road",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0470-2025",
      "product_description": "Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540. Manufactured by: Macleods Pharmaceuticals Ltd. Sarigam, Valsad, Gujarat, India, NDC 33342-398-44.",
      "product_quantity": "1,344- 1000 count bottles",
      "reason_for_recall": "Presence of a foreign substance: black hair found embedded in tablet.",
      "recall_initiation_date": "20250529",
      "center_classification_date": "20250612",
      "report_date": "20250618",
      "code_info": "Lot #: MLF2401A, Exp 01/31/2026",
      "more_code_info": ""
    }
  ]
}