{
  "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": "Northbrook",
      "state": "IL",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "NDA204096"
        ],
        "brand_name": [
          "ASTAGRAF XL"
        ],
        "generic_name": [
          "TACROLIMUS EXTENDED-RELEASE CAPSULES"
        ],
        "manufacturer_name": [
          "Astellas Pharma US, Inc."
        ],
        "product_ndc": [
          "0469-0647",
          "0469-0677",
          "0469-0687"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
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        ],
        "substance_name": [
          "TACROLIMUS"
        ],
        "rxcui": [
          "1431971",
          "1431977",
          "1431980",
          "1431982",
          "1431985",
          "1431987"
        ],
        "spl_id": [
          "4ecfe626-bf9c-4889-a1d4-64b03d60eaf8"
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        "spl_set_id": [
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        "package_ndc": [
          "0469-0647-73",
          "0469-0647-11",
          "0469-0677-73",
          "0469-0677-11",
          "0469-0687-73",
          "0469-0687-11"
        ],
        "is_original_packager": [
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        ],
        "unii": [
          "WM0HAQ4WNM"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96008",
      "recalling_firm": "Astellas Pharma US Inc.",
      "address_1": "2375 Waterview Dr",
      "address_2": "",
      "postal_code": "60062-6145",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0210-2025",
      "product_description": "Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by: Astellas Pharma US Inc., Northbrook, IL 60062, NDC 0469-0647-73.",
      "product_quantity": "3,500 30-count bottles",
      "reason_for_recall": "Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules",
      "recall_initiation_date": "20241223",
      "center_classification_date": "20250129",
      "report_date": "20250205",
      "code_info": "Lot# 0R3092A, EXP 03/31/2026",
      "more_code_info": ""
    }
  ]
}