{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA208934"
        ],
        "brand_name": [
          "TADALAFIL"
        ],
        "generic_name": [
          "TADALAFIL"
        ],
        "manufacturer_name": [
          "NorthStar RxLLC"
        ],
        "product_ndc": [
          "16714-074",
          "16714-075",
          "16714-076",
          "16714-077"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TADALAFIL"
        ],
        "rxcui": [
          "402019",
          "403957",
          "484814",
          "757707"
        ],
        "spl_id": [
          "2b1383b3-acce-43df-9aad-2d92c439b80f"
        ],
        "spl_set_id": [
          "594acc15-a5bc-43b5-9659-a864b2c46eea"
        ],
        "package_ndc": [
          "16714-074-01",
          "16714-074-02",
          "16714-075-01",
          "16714-076-01",
          "16714-077-01"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175599",
          "N0000020026"
        ],
        "pharm_class_epc": [
          "Phosphodiesterase 5 Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Phosphodiesterase 5 Inhibitors [MoA]"
        ],
        "unii": [
          "742SXX0ICT"
        ]
      },
      "product_type": "Drugs",
      "event_id": "88873",
      "recalling_firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
      "address_1": "2 Independence Way",
      "address_2": "N/A",
      "postal_code": "08540-6620",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed to one distributor who may have further distribute the product nationwide.",
      "recall_number": "D-0231-2022",
      "product_description": "Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-077-01",
      "product_quantity": "36,786 30-count bottles",
      "reason_for_recall": "Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.",
      "recall_initiation_date": "20211025",
      "center_classification_date": "20211112",
      "termination_date": "20220901",
      "report_date": "20211117",
      "code_info": "Lot # DNC0814A, DNC0815A, Exp. Date 04/2023",
      "more_code_info": ""
    }
  ]
}