{
  "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": [
          "ANDA210465"
        ],
        "brand_name": [
          "LANSOPRAZOLE"
        ],
        "generic_name": [
          "LANSOPRAZOLE"
        ],
        "manufacturer_name": [
          "Dr.Reddys Laboratories Inc"
        ],
        "product_ndc": [
          "43598-561",
          "43598-560"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LANSOPRAZOLE"
        ],
        "rxcui": [
          "351260",
          "351261"
        ],
        "spl_id": [
          "9d1837b8-8381-eef1-3cc8-a1738b66b5d6"
        ],
        "spl_set_id": [
          "656bc92a-1f95-047d-cd27-724073e63fe6"
        ],
        "package_ndc": [
          "43598-560-79",
          "43598-560-78",
          "43598-561-79",
          "43598-561-78",
          "4359856179"
        ],
        "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": "90601",
      "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 in the USA",
      "recall_number": "D-1288-2022",
      "product_description": "Lansoprazole Delayed-Release Orally Disintegrating Tablets, 35 mg, 100-count blisters per carton, 10 Packs of 10 Tablets Each, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, blister barcode 4359856179, NDC 43598-561-78",
      "product_quantity": "2,639 cartons",
      "reason_for_recall": "FAILED DISSOLUTION SPECIFICATIONS",
      "recall_initiation_date": "20220713",
      "center_classification_date": "20220722",
      "termination_date": "20231206",
      "report_date": "20220803",
      "code_info": "Lot T2100515, Exp 01/2023",
      "more_code_info": ""
    }
  ]
}