{
  "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": "2026-06-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Seymour",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA203899"
        ],
        "brand_name": [
          "NIACIN"
        ],
        "generic_name": [
          "NIACIN"
        ],
        "manufacturer_name": [
          "Lannett Company, Inc."
        ],
        "product_ndc": [
          "62175-320",
          "62175-322"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "NIACIN"
        ],
        "rxcui": [
          "1098134",
          "1098141"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "62175-320-46",
          "62175-320-43",
          "62175-322-46",
          "62175-322-43"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0362175320469"
        ],
        "nui": [
          "N0000175594",
          "M0014839"
        ],
        "pharm_class_epc": [
          "Nicotinic Acid [EPC]"
        ],
        "pharm_class_cs": [
          "Nicotinic Acids [CS]"
        ],
        "unii": [
          "2679MF687A"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99107",
      "recalling_firm": "Lannett Company Inc.",
      "address_1": "1101 C Ave W",
      "address_2": "",
      "postal_code": "47274-3342",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0584-2026",
      "product_description": "Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 62175-322-46.",
      "product_quantity": "3984 bottles",
      "reason_for_recall": "Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.",
      "recall_initiation_date": "20260527",
      "center_classification_date": "20260610",
      "report_date": "20260610",
      "code_info": "Lot #: 25282724A, Exp. Date 2027/01",
      "more_code_info": ""
    }
  ]
}