{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Bridgewater",
      "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": "66117",
      "recalling_firm": "Dr. Reddy's Laboratories, Inc.",
      "address_1": "200 Somerset Corporate Blvd Fl 7th",
      "address_2": "N/A",
      "postal_code": "08807-2862",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide (& Puerto Rico)",
      "recall_number": "D-1042-2013",
      "product_description": "IBU (TM) IBUPROFEN Tablets, USP, 800 mg, 500 -count bottle,(NDC 55111-684-05) Rx only, Distributed by Dr. Reddy's Laboratories, Inc., Bridgewater, NJ  08807 USA.",
      "product_quantity": "18852 bottles",
      "reason_for_recall": "Labeling: Incorrect or missing lot and/or exp date- This product is being recalled due to an incorrect expiration date of 05/2017. The correct expiration date is 10/2016.",
      "recall_initiation_date": "20130829",
      "center_classification_date": "20130913",
      "termination_date": "20140320",
      "report_date": "20130925",
      "code_info": "Lot # L300192; Exp. 05/2017",
      "more_code_info": ""
    }
  ]
}