{
  "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": "Terminated",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA201581"
        ],
        "brand_name": [
          "MONTELUKAST SODIUM"
        ],
        "generic_name": [
          "MONTELUKAST SODIUM"
        ],
        "manufacturer_name": [
          "Dr.Reddy's Laboratories Limited"
        ],
        "product_ndc": [
          "55111-593",
          "55111-725",
          "55111-594"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "MONTELUKAST SODIUM"
        ],
        "rxcui": [
          "200224",
          "242438",
          "311759"
        ],
        "spl_id": [
          "8bc013e8-5324-099d-e603-d78012b126bd"
        ],
        "spl_set_id": [
          "3d4451a9-d73d-b9de-68ec-853bfeff6e4b"
        ],
        "package_ndc": [
          "55111-725-30",
          "55111-725-90",
          "55111-725-01",
          "55111-725-10",
          "55111-725-79",
          "55111-725-78",
          "55111-593-30",
          "55111-593-90",
          "55111-593-05",
          "55111-593-79",
          "55111-593-78",
          "55111-594-30",
          "55111-594-90",
          "55111-594-05",
          "55111-594-79",
          "55111-594-78"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "U1O3J18SFL"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93225",
      "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": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0086-2024",
      "product_description": "Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made in India, NDC# 55111-725-10.",
      "product_quantity": "1,656 bottles",
      "reason_for_recall": "Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.",
      "recall_initiation_date": "20231013",
      "center_classification_date": "20231103",
      "termination_date": "20240909",
      "report_date": "20231115",
      "code_info": "Lot # C2305569, Exp. date 03/31/2026",
      "more_code_info": ""
    }
  ]
}