{
  "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": "Ongoing",
      "city": "Morristown",
      "state": "NJ",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA202097"
        ],
        "brand_name": [
          "FENTANYL SYSTEM"
        ],
        "generic_name": [
          "FENTANYL"
        ],
        "manufacturer_name": [
          "ALVOGEN"
        ],
        "product_ndc": [
          "47781-423",
          "47781-424",
          "47781-426",
          "47781-427",
          "47781-428"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TRANSDERMAL"
        ],
        "substance_name": [
          "FENTANYL"
        ],
        "rxcui": [
          "197696",
          "245134",
          "245135",
          "245136",
          "577057"
        ],
        "spl_id": [
          "4b8493ea-0ce4-6949-e063-6294a90a8861"
        ],
        "spl_set_id": [
          "242759ef-cb6d-4e3e-9f8d-5e31efa1f289"
        ],
        "package_ndc": [
          "47781-423-11",
          "47781-423-47",
          "47781-424-11",
          "47781-424-47",
          "47781-426-11",
          "47781-426-47",
          "47781-427-11",
          "47781-427-47",
          "47781-428-11",
          "47781-428-47"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175684",
          "N0000175690"
        ],
        "pharm_class_moa": [
          "Full Opioid Agonists [MoA]"
        ],
        "pharm_class_epc": [
          "Opioid Agonist [EPC]"
        ],
        "unii": [
          "UF599785JZ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96222",
      "recalling_firm": "Alvogen, Inc",
      "address_1": "44 Whippany Rd Ste 300",
      "address_2": "N/A",
      "postal_code": "07960-4558",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA Nationwide",
      "recall_number": "D-0245-2025",
      "product_description": "Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058, Manufactured by: Kindeva Drug Delivery L/P, Northridge, CA 91324, NDC 47781-424-47.",
      "product_quantity": "112,128 cartons (5 pouches/carton)",
      "reason_for_recall": "Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.",
      "recall_initiation_date": "20250131",
      "center_classification_date": "20250220",
      "report_date": "20250226",
      "code_info": "Lot #: 108319, Exp: 04/30/2027"
    }
  ]
}