{
  "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": "2026-10-14",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Bridgewater",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA216055"
        ],
        "brand_name": [
          "ESTRADIOL"
        ],
        "generic_name": [
          "ESTRADIOL TRANSDERMAL"
        ],
        "manufacturer_name": [
          "Amneal Pharmaceuticals NY LLC"
        ],
        "product_ndc": [
          "69238-2448",
          "69238-2452",
          "69238-2451",
          "69238-2450",
          "69238-2449"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ESTRADIOL"
        ],
        "rxcui": [
          "2619677",
          "2619679",
          "2619681",
          "2619683",
          "2619685"
        ],
        "spl_id": [
          "cebb61d3-34b7-44a7-aae7-d23e21651713"
        ],
        "spl_set_id": [
          "9669a0e3-27e2-4f6c-961c-7a67e9f84cc8"
        ],
        "package_ndc": [
          "69238-2452-1",
          "69238-2452-3",
          "69238-2451-1",
          "69238-2451-3",
          "69238-2450-1",
          "69238-2450-3",
          "69238-2449-1",
          "69238-2449-3",
          "69238-2448-1",
          "69238-2448-3"
        ],
        "is_original_packager": [
          true
        ],
        "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": "99742",
      "recalling_firm": "Amneal Pharmaceuticals, LLC",
      "address_1": "400 Crossing Blvd Fl 3",
      "address_2": "",
      "postal_code": "08807-2863",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA.",
      "recall_number": "D-0873-2026",
      "product_description": "Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08907, NDC 69238-2452-3.",
      "product_quantity": "2,592 30-count cartons",
      "reason_for_recall": "Defective Container; packets were found to be either empty or partially full.",
      "recall_initiation_date": "20260908",
      "center_classification_date": "20260928",
      "report_date": "20261007",
      "code_info": "Lot # 245226005B, Exp Date: 04/30/2028.",
      "more_code_info": ""
    }
  ]
}