{
  "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": "2026-07-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "West Palm Beach",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "POVI-ONE"
        ],
        "generic_name": [
          "POVIDONE-IODINE 10% TOPICAL"
        ],
        "manufacturer_name": [
          "Elevate Oral Care"
        ],
        "product_ndc": [
          "57511-0611"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "POVIDONE-IODINE"
        ],
        "spl_id": [
          "3f1914a6-3095-23c3-e063-6294a90ac03a"
        ],
        "spl_set_id": [
          "f5252b4f-5e14-509e-e053-2995a90a6db8"
        ],
        "package_ndc": [
          "57511-0611-1"
        ],
        "original_packager_product_ndc": [
          "68599-3500"
        ],
        "nui": [
          "N0000175486",
          "M0011640"
        ],
        "pharm_class_epc": [
          "Antiseptic [EPC]"
        ],
        "pharm_class_cs": [
          "Iodine [CS]"
        ],
        "unii": [
          "85H0HZU99M"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99191",
      "recalling_firm": "Elevate Oral Care",
      "address_1": "346 Pike Rd Ste 5",
      "address_2": "Suite 1, 5, 13, & 23",
      "postal_code": "33411-3819",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0627-2026",
      "product_description": "Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346 Pike Road, Suite 6, West Palm Beach, FL 33411, NDC 57511-0611-1.",
      "product_quantity": "8132 6-packs & 2262 2-packs",
      "reason_for_recall": "sub potency",
      "recall_initiation_date": "20260604",
      "center_classification_date": "20260625",
      "report_date": "20260701",
      "code_info": "Lots PO062402, Exp Date 6/30/2026, PO072401, Exp Date 7/30/2026, PO092401,    Exp Date 9/30/2026, PO102401,    Exp Date 10/31/2026 & PO102402, Exp Date 10/31/2026."
    }
  ]
}