{
  "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": "2026-06-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Baudette",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA217610"
        ],
        "brand_name": [
          "ESTRADIOL"
        ],
        "generic_name": [
          "ESTRADIOL"
        ],
        "manufacturer_name": [
          "ANI Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "70954-530",
          "70954-531",
          "70954-532",
          "70954-533",
          "70954-534"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ESTRADIOL"
        ],
        "rxcui": [
          "2619677",
          "2619679",
          "2619681",
          "2619683",
          "2619685"
        ],
        "spl_id": [
          "98963341-a7e0-4b8d-bb56-be1820611090"
        ],
        "spl_set_id": [
          "ff28c624-906d-459c-8b8c-27cb1a664e12"
        ],
        "package_ndc": [
          "70954-531-10",
          "70954-531-20",
          "70954-532-10",
          "70954-532-20",
          "70954-533-10",
          "70954-533-20",
          "70954-534-10",
          "70954-534-20",
          "70954-530-10",
          "70954-530-20"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0370954531104",
          "0370954530107",
          "0370954532101",
          "0370954534105",
          "0370954533108"
        ],
        "nui": [
          "M0447348",
          "N0000175825",
          "N0000000100"
        ],
        "pharm_class_cs": [
          "Estradiol Congeners [CS]"
        ],
        "pharm_class_epc": [
          "Estrogen [EPC]"
        ],
        "pharm_class_moa": [
          "Estrogen Receptor Agonists [MoA]"
        ],
        "unii": [
          "4TI98Z838E"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98947",
      "recalling_firm": "ANI Pharmaceuticals, Inc.",
      "address_1": "210 W Main St",
      "address_2": "",
      "postal_code": "56623-2467",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0543-2026",
      "product_description": "Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623.  NDC 70954-531-20",
      "product_quantity": "3964 Cartons",
      "reason_for_recall": "Defective Container; packets were found to be either empty or partially full.",
      "recall_initiation_date": "20260512",
      "center_classification_date": "20260520",
      "report_date": "20260527",
      "code_info": "Lot M251109, exp Nov 2027",
      "more_code_info": ""
    }
  ]
}