{
  "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": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA075682"
        ],
        "brand_name": [
          "IBU"
        ],
        "generic_name": [
          "IBUPROFEN"
        ],
        "manufacturer_name": [
          "Dr. Reddy's Laboratories Limited"
        ],
        "product_ndc": [
          "55111-682",
          "55111-683",
          "55111-684"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "IBUPROFEN"
        ],
        "rxcui": [
          "197805",
          "197806",
          "197807",
          "206905",
          "206913",
          "206917"
        ],
        "spl_id": [
          "a7977972-4353-9ca0-d419-e37039010e7d"
        ],
        "spl_set_id": [
          "24731405-219c-79b4-ecf0-7d5fbfda94ba"
        ],
        "package_ndc": [
          "55111-682-09",
          "55111-682-01",
          "55111-682-05",
          "55111-683-30",
          "55111-683-50",
          "55111-683-09",
          "55111-683-01",
          "55111-683-05",
          "55111-684-30",
          "55111-684-50",
          "55111-684-60",
          "55111-684-09",
          "55111-684-01",
          "55111-684-05"
        ],
        "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": "95098",
      "recalling_firm": "Dr. Reddy's Laboratories, Inc.",
      "address_1": "107 College Rd E",
      "address_2": "",
      "postal_code": "08540-6623",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "",
      "distribution_pattern": "Nationwide in the USA and Puerto Rico",
      "recall_number": "D-0645-2024",
      "product_description": "IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-683-01 - 100 Tablets per bottle, b)NDC 5511-683-05 - 500 Tablets per bottle.",
      "product_quantity": "31,802 bottles",
      "reason_for_recall": "Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.",
      "recall_initiation_date": "20240806",
      "center_classification_date": "20240826",
      "report_date": "20240904",
      "code_info": "a)NDC 55111-683-01  Lots C2207527, Exp 5/31/2026; C2210864, Exp 9/30/2026; C2213018, Exp 11/30/2026.  b)NDC 5511-683-05  Lots C2207528, Exp 5/31/2026; C2210860, Exp 9/30/2026; C2213016, C2213017, Exp 11/30/2026; C2301852, C2302056, C2302057, Exp 1/31/2027.",
      "more_code_info": ""
    }
  ]
}