{
  "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": "Indianapolis",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA209167"
        ],
        "brand_name": [
          "TADALAFIL"
        ],
        "generic_name": [
          "TADALAFIL"
        ],
        "manufacturer_name": [
          "Northwind Health Company, LLC"
        ],
        "product_ndc": [
          "51655-487"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TADALAFIL"
        ],
        "rxcui": [
          "403957"
        ],
        "spl_id": [
          "490f748c-4026-e630-e063-6294a90ac547"
        ],
        "spl_set_id": [
          "f317fe1e-d7c4-fb8b-e053-2a95a90a5445"
        ],
        "package_ndc": [
          "51655-487-52"
        ],
        "original_packager_product_ndc": [
          "16729-370"
        ],
        "nui": [
          "N0000175599",
          "N0000020026"
        ],
        "pharm_class_epc": [
          "Phosphodiesterase 5 Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Phosphodiesterase 5 Inhibitors [MoA]"
        ],
        "unii": [
          "742SXX0ICT"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91944",
      "recalling_firm": "Northwind Pharmaceuticals LLC",
      "address_1": "4838 Fletcher Ave Ste 1000",
      "address_2": "N/A",
      "postal_code": "46203-1642",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Nationwide with the United States",
      "recall_number": "D-0554-2023",
      "product_description": "Tadalafil Tablets, USP 5 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.  NDC 51655-487-52",
      "product_quantity": "23 bottles",
      "reason_for_recall": "CGMP Deviations",
      "recall_initiation_date": "20230316",
      "center_classification_date": "20230426",
      "report_date": "20230503",
      "code_info": "Lot #: F114302001, Exp. Date 05/31/2023"
    }
  ]
}