{
  "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": [
          "ANDA091269"
        ],
        "brand_name": [
          "LANSOPRAZOLE"
        ],
        "generic_name": [
          "LANSOPRAZOLE"
        ],
        "manufacturer_name": [
          "Dr.Reddy's Laboratories Ltd."
        ],
        "product_ndc": [
          "55111-398",
          "55111-399"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LANSOPRAZOLE"
        ],
        "rxcui": [
          "311277",
          "596843"
        ],
        "spl_id": [
          "c8eb1d41-1fd2-7c06-486c-e6abf08faa6d"
        ],
        "spl_set_id": [
          "82174fcc-1b0f-2068-7fc4-db335b43b5e2"
        ],
        "package_ndc": [
          "55111-398-30",
          "55111-398-60",
          "55111-398-90",
          "55111-398-01",
          "55111-398-05",
          "55111-398-79",
          "55111-399-30",
          "55111-399-60",
          "55111-399-90",
          "55111-399-01",
          "55111-399-05",
          "55111-399-79"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175525",
          "N0000000147",
          "N0000009724"
        ],
        "pharm_class_epc": [
          "Proton Pump Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Proton Pump Inhibitors [MoA]"
        ],
        "pharm_class_pe": [
          "Inhibition Gastric Acid Secretion [PE]"
        ],
        "unii": [
          "0K5C5T2QPG"
        ]
      },
      "product_type": "Drugs",
      "event_id": "89871",
      "recalling_firm": "Dr. Reddy's Laboratories, Inc.",
      "address_1": "107 College Rd E",
      "address_2": "N/A",
      "postal_code": "08540-6623",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0737-2022",
      "product_description": "Lansoprazole Delayed-Release Capsules, USP, 15 mg, a) 30-count bottle, (NDC 55111-398-30), b) 90-count bottle, (55111-398-90), Rx Only, Manufactured. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India",
      "product_quantity": "8,352 bottles (30-count), 1,368 bottles (90-count)",
      "reason_for_recall": "Failed Dissolution Specifications; during long term stability testing.",
      "recall_initiation_date": "20220323",
      "center_classification_date": "20220331",
      "termination_date": "20240202",
      "report_date": "20220406",
      "code_info": "Lot # a) C2103093, Exp. 12/2023; b)C2103092, Exp. 12/2023."
    }
  ]
}