{
  "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": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA209495"
        ],
        "brand_name": [
          "ESOMEPRAZOLE MAGNESIUM"
        ],
        "generic_name": [
          "ESOMEPRAZOLE MAGNESIUM"
        ],
        "manufacturer_name": [
          "Glenmark Pharmaceuticals Inc., USA"
        ],
        "product_ndc": [
          "68462-390",
          "68462-391"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ESOMEPRAZOLE MAGNESIUM"
        ],
        "rxcui": [
          "606726",
          "606730"
        ],
        "spl_id": [
          "5eef4592-c7ef-454c-88a9-62671fff9088"
        ],
        "spl_set_id": [
          "a6430045-ae60-4a16-92b9-2975cb497629"
        ],
        "package_ndc": [
          "68462-390-30",
          "68462-390-90",
          "68462-390-10",
          "68462-391-30",
          "68462-391-90",
          "68462-391-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368462391303",
          "0368462390306"
        ],
        "unii": [
          "R6DXU4WAY9"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93262",
      "recalling_firm": "Glenmark Pharmaceuticals Inc., USA",
      "address_1": "750 Corporate Dr",
      "address_2": "N/A",
      "postal_code": "07430-2009",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0112-2024",
      "product_description": "Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-count Bottle, NDC 68462-390-10: RX Only, Manufactured for: Glenmark, Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India,",
      "product_quantity": "8,448 30-count bottles, 168 1000-count bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time point in long term stability study (25¿C/60% RH).",
      "recall_initiation_date": "20231023",
      "center_classification_date": "20231120",
      "termination_date": "20240705",
      "report_date": "20231129",
      "code_info": "Lot # 17220002, Exp Date 11/30/2023",
      "more_code_info": ""
    }
  ]
}