{
  "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": "Terminated",
      "city": "Whippany",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M005"
        ],
        "brand_name": [
          "LOTRIMIN DAILY PREVENTION DEO"
        ],
        "generic_name": [
          "TOLNAFTATE"
        ],
        "manufacturer_name": [
          "Bayer HealthCare LLC."
        ],
        "product_ndc": [
          "11523-0010"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "TOLNAFTATE"
        ],
        "rxcui": [
          "705934"
        ],
        "spl_id": [
          "4526ca36-993e-b574-e063-6294a90a8fba"
        ],
        "spl_set_id": [
          "9e8bfb78-ad81-93d0-e053-2995a90aa41d"
        ],
        "package_ndc": [
          "11523-0010-1",
          "11523-0010-2",
          "0004110059"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "06KB629TKV"
        ],
        "upc": [
          "041100587206",
          "011017408239"
        ]
      },
      "product_type": "Drugs",
      "event_id": "88677",
      "recalling_firm": "Bayer Healthcare Pharmaceuticals Inc.",
      "address_1": "100 Bayer Blvd",
      "address_2": "N/A",
      "postal_code": "07981-1544",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.",
      "recall_number": "D-0254-2022",
      "product_description": "LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, UPC 0 41100 58720 6, NDC 11523-0010-2; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, Packaged with LOTRIMIN ULTRA (butenafine hydrochloride 1%) cream, UPC 0 11017 40823 9, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Japan,  ECOM PK   UPC 00041100590756 NDC 11523-0010-2",
      "product_quantity": "579,456 units",
      "reason_for_recall": "cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facility where other lots were found to be contaminated with benzene.",
      "recall_initiation_date": "20211001",
      "center_classification_date": "20211118",
      "termination_date": "20230626",
      "report_date": "20211124",
      "code_info": "Lot # NAA8997, EXP 01/31/2022; NAA8EK8, EXP 02/28/2022; NAA9E18, NAA9LFP, NAA9T53, NAA5RW, EXP 08/31/2022;",
      "more_code_info": ""
    }
  ]
}