{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "New York",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA012151"
        ],
        "brand_name": [
          "ALDACTONE"
        ],
        "generic_name": [
          "SPIRONOLACTONE"
        ],
        "manufacturer_name": [
          "Pfizer Laboratories Div Pfizer Inc"
        ],
        "product_ndc": [
          "0025-1001",
          "0025-1041",
          "0025-1031"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SPIRONOLACTONE"
        ],
        "rxcui": [
          "198222",
          "198223",
          "200817",
          "200820",
          "200825",
          "313096"
        ],
        "spl_id": [
          "22946678-dcad-4518-9bc6-cbdf51a38c16"
        ],
        "spl_set_id": [
          "0fed2822-3a03-4b64-9857-c682fcd462bc"
        ],
        "package_ndc": [
          "0025-1001-31",
          "0025-1041-31",
          "0025-1031-31"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0300251001314",
          "0300251031311",
          "0300251041310"
        ],
        "nui": [
          "N0000175557",
          "N0000011310"
        ],
        "pharm_class_epc": [
          "Aldosterone Antagonist [EPC]"
        ],
        "pharm_class_moa": [
          "Aldosterone Antagonists [MoA]"
        ],
        "unii": [
          "27O7W4T232"
        ]
      },
      "product_type": "Drugs",
      "event_id": "66124",
      "recalling_firm": "Pfizer Us Pharmaceutical Group",
      "address_1": "235 E 42nd St",
      "address_2": "",
      "postal_code": "10017-5703",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide",
      "recall_number": "D-014-2014",
      "product_description": "Aldactone (spironolactone) tablets, USP, 100 mg, 100-count bottles, Rx only, Distributed by G.D. Searle, Division of Pfizer Inc, NY, NY  10017, NDC 0025-1031-31",
      "product_quantity": "31 bottles",
      "reason_for_recall": "Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site.",
      "recall_initiation_date": "20130904",
      "center_classification_date": "20131120",
      "termination_date": "20170413",
      "report_date": "20131127",
      "code_info": "Lot #: V121573, Exp 05/17",
      "more_code_info": ""
    }
  ]
}