{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Warren",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA020812"
        ],
        "brand_name": [
          "INFANTS ADVIL"
        ],
        "generic_name": [
          "IBUPROFEN"
        ],
        "manufacturer_name": [
          "Haleon US Holdings LLC"
        ],
        "product_ndc": [
          "0573-0191"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "IBUPROFEN"
        ],
        "rxcui": [
          "204442",
          "731531"
        ],
        "spl_id": [
          "9f156faa-6bf8-483c-837d-050e40ec0cc5"
        ],
        "spl_set_id": [
          "db5ed801-7a7e-3c83-0172-77f914daaa5a"
        ],
        "package_ndc": [
          "0573-0191-20",
          "0573-0191-50",
          "0573-0191-22",
          "0573-0191-75",
          "0057301917",
          "0057301915"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000000160",
          "M0001335",
          "N0000175722"
        ],
        "pharm_class_moa": [
          "Cyclooxygenase Inhibitors [MoA]"
        ],
        "pharm_class_cs": [
          "Anti-Inflammatory Agents, Non-Steroidal [CS]"
        ],
        "pharm_class_epc": [
          "Nonsteroidal Anti-inflammatory Drug [EPC]"
        ],
        "unii": [
          "WK2XYI10QM"
        ]
      },
      "product_type": "Drugs",
      "event_id": "85224",
      "recalling_firm": "Glaxosmithkline Consumer Healthcare Holdings",
      "address_1": "184 Liberty Corner Rd",
      "address_2": "N/A",
      "postal_code": "07059-6796",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed throughout the United States, including Puerto Rico.",
      "recall_number": "D-1067-2020",
      "product_description": "Ibuprofen 50 mg per 1.25 mL Oral Suspension  Advil Infant Concentrated Drops White Grape  0.75 oz. and 1 oz. bottles  NDC 0573-0191-75 (0.75 oz.)  NDC 0573-0191-50 (1 oz.)",
      "product_quantity": "151,056 bottles",
      "reason_for_recall": "Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.",
      "recall_initiation_date": "20200316",
      "center_classification_date": "20200326",
      "termination_date": "20211028",
      "report_date": "20200401",
      "code_info": "Batch/Lot #   R73761, exp. date 01/31/2021, Item # F00573019175, 0.75 oz.   R74936, exp. date 02/28/2021, Item # F00573019175, 0.75 oz.  R56290, exp. date 03/31/2020, Item # F00573019150, 1 oz.  R60959, exp. date 02/28/2021, Item # F00573019150, 1 oz.   R78826, exp. date 11/30/2021, Item # F00573019150, 1 oz.   9335UA, exp. date 01/31/2021, item # F00573019175A - Co-package  9336UA, exp. date 02/28/2021, item # F00573019175A - Co-package",
      "more_code_info": ""
    }
  ]
}