{
  "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,
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    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Summitt",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M013"
        ],
        "brand_name": [
          "TYLENOL EXTRA STRENGTH"
        ],
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        ],
        "product_ndc": [
          "50580-378"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
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        "substance_name": [
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        "package_ndc": [
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          "50580-378-03",
          "50580-378-04",
          "50580-378-05",
          "50580-378-06",
          "50580-378-07",
          "50580-378-08",
          "50580-378-37"
        ],
        "is_original_packager": [
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        ],
        "unii": [
          "362O9ITL9D"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97850",
      "recalling_firm": "Kenvue Brands LLC",
      "address_1": "1 Kenvue Way",
      "address_2": "N/A",
      "postal_code": "07901",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide - CO, IL, OH and IN.",
      "recall_number": "D-0121-2026",
      "product_description": "TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, Fort Washington, PA 19034, NDC: 50580-378-04.",
      "product_quantity": "3,816 bottles",
      "reason_for_recall": "Defective Container",
      "recall_initiation_date": "20251021",
      "center_classification_date": "20251028",
      "report_date": "20251105",
      "code_info": "Lot: EJA022, expiry: 04/30/2028"
    }
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}