{
  "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": [
          "51655-473"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TADALAFIL"
        ],
        "rxcui": [
          "402019"
        ],
        "spl_id": [
          "490f1639-8284-d34e-e063-6394a90aa16e"
        ],
        "spl_set_id": [
          "f3092f5a-b976-91ab-e053-2995a90a9b50"
        ],
        "package_ndc": [
          "51655-473-54",
          "51655-473-87"
        ],
        "original_packager_product_ndc": [
          "16729-372"
        ],
        "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-0553-2023",
      "product_description": "Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count bottles (NDC 51655-473-54), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.",
      "product_quantity": "a)164 bottles; b) 198 bottles",
      "reason_for_recall": "CGMP Deviations",
      "recall_initiation_date": "20230316",
      "center_classification_date": "20230426",
      "report_date": "20230503",
      "code_info": "a) Lot #: F113892002, Exp. Date 08/31/2023; F113892201, Exp. Date 11/30/2023 b) Lot #: F113892001, Exp. Date 08/31/2023; F113892202, Exp. Date 11/30/2023; F113892203, Exp. Date 12/31/2023"
    }
  ]
}