{
  "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": "Minneapolis",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA062225"
        ],
        "brand_name": [
          "NYSTATIN"
        ],
        "generic_name": [
          "NYSTATIN"
        ],
        "manufacturer_name": [
          "Padagis Israel Pharmaceuticals Ltd"
        ],
        "product_ndc": [
          "45802-059"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "NYSTATIN"
        ],
        "rxcui": [
          "543546"
        ],
        "spl_id": [
          "e2839c50-5b8f-4e7b-9636-d22687038a89"
        ],
        "spl_set_id": [
          "e630aa3d-11a6-4300-942a-cbdf2d016f77"
        ],
        "package_ndc": [
          "45802-059-35",
          "45802-059-11"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175498",
          "M0017172"
        ],
        "pharm_class_epc": [
          "Polyene Antifungal [EPC]"
        ],
        "pharm_class_cs": [
          "Polyenes [CS]"
        ],
        "unii": [
          "BDF1O1C72E"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99283",
      "recalling_firm": "Padagis US LLC",
      "address_1": "3940 Quebec Ave N",
      "address_2": "",
      "postal_code": "55427-1244",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA Nationwide",
      "recall_number": "D-0677-2026",
      "product_description": "Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-35",
      "product_quantity": "180,936 tubes",
      "reason_for_recall": "Subpotent Drug: Low out of specification assay results performed during long-term stability testing.",
      "recall_initiation_date": "20260623",
      "center_classification_date": "20260713",
      "report_date": "20260722",
      "code_info": "Lot #: 205060, Exp 09/30/2027",
      "more_code_info": ""
    }
  ]
}