{
  "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": "Hawthorne",
      "state": "NY",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA074249"
        ],
        "brand_name": [
          "CLOBETASOL PROPIONATE"
        ],
        "generic_name": [
          "CLOBETASOL PROPIONATE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "51672-1258",
          "51672-1294",
          "51672-1259"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "CLOBETASOL PROPIONATE"
        ],
        "rxcui": [
          "861434",
          "861448",
          "861495"
        ],
        "spl_id": [
          "4db5c318-4c64-4e2c-e063-6294a90aa7f9"
        ],
        "spl_set_id": [
          "4a761afb-a48a-4a5a-8700-ad93601a260f"
        ],
        "package_ndc": [
          "51672-1294-1",
          "51672-1294-2",
          "51672-1294-3",
          "51672-1258-1",
          "51672-1258-2",
          "51672-1258-6",
          "51672-1258-3",
          "51672-1259-1",
          "51672-1259-2",
          "51672-1259-6",
          "51672-1259-3"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0351672129422"
        ],
        "unii": [
          "779619577M"
        ]
      },
      "product_type": "Drugs",
      "event_id": "89241",
      "recalling_firm": "Taro Pharmaceuticals U.S.A., Inc.",
      "address_1": "3 Skyline Dr",
      "address_2": "N/A",
      "postal_code": "10532-2174",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Two distributors in UT and LA who could have further distributed to the retail level nationwide in the USA.",
      "recall_number": "D-0375-2022",
      "product_description": "Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC 51672-1259-3",
      "product_quantity": "96 tubes",
      "reason_for_recall": "Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria",
      "recall_initiation_date": "20211215",
      "center_classification_date": "20220118",
      "termination_date": "20231204",
      "report_date": "20220119",
      "code_info": "Lot# AC13786, exp. date DEC 2022"
    }
  ]
}