{
  "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": "Baltimore",
      "state": "MD",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA077321"
        ],
        "brand_name": [
          "LISINOPRIL"
        ],
        "generic_name": [
          "LISINOPRIL"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "68180-512",
          "68180-513",
          "68180-517",
          "68180-980",
          "68180-981",
          "68180-982",
          "68180-979",
          "68180-514",
          "68180-515",
          "68180-516"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LISINOPRIL"
        ],
        "rxcui": [
          "197884",
          "205326",
          "311353",
          "311354",
          "314076",
          "314077"
        ],
        "spl_id": [
          "6723a96d-02f8-40c2-95ec-89a7053a7117"
        ],
        "spl_set_id": [
          "7d6c31e2-b5a4-4279-8013-a8dad37ea73b"
        ],
        "package_ndc": [
          "68180-512-02",
          "68180-512-30",
          "68180-512-09",
          "68180-512-01",
          "68180-512-03",
          "68180-513-30",
          "68180-513-03",
          "68180-513-01",
          "68180-513-09",
          "68180-513-02",
          "68180-513-05",
          "68180-517-03",
          "68180-517-01",
          "68180-517-30",
          "68180-517-09",
          "68180-517-04",
          "68180-517-02",
          "68180-980-03",
          "68180-980-30",
          "68180-980-01",
          "68180-980-09",
          "68180-980-05",
          "68180-980-02",
          "68180-981-01",
          "68180-981-03",
          "68180-981-30",
          "68180-981-09",
          "68180-981-02",
          "68180-981-05",
          "68180-982-01",
          "68180-982-02",
          "68180-982-30",
          "68180-982-03",
          "68180-982-09",
          "68180-979-01",
          "68180-979-03",
          "68180-979-30",
          "68180-979-09",
          "68180-514-01",
          "68180-514-02",
          "68180-514-03",
          "68180-514-09",
          "68180-514-30",
          "68180-514-05",
          "68180-515-01",
          "68180-515-02",
          "68180-515-03",
          "68180-515-09",
          "68180-515-30",
          "68180-515-05",
          "68180-516-01",
          "68180-516-02",
          "68180-516-03",
          "68180-516-09",
          "68180-516-30"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368180513018",
          "0368180512028",
          "0368180513032"
        ],
        "unii": [
          "E7199S1YWR"
        ]
      },
      "product_type": "Drugs",
      "event_id": "74945",
      "recalling_firm": "Lupin Pharmaceuticals Inc.",
      "address_1": "111 S Calvert St Fl 21ST",
      "address_2": "",
      "postal_code": "21202-6174",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "All product distributed domestically in the US. No recalled product was distributed to U.S. Government Agency consignees directly by Lupin.  No recalled product was distributed to any foreign consignees by Lupin.",
      "recall_number": "D-1502-2016",
      "product_description": "Lisinopril Tablets USP, 30 mg, packaged in a) 500-count bottles (NDC 68180-516-02) and b) 100-count bottles (NDC 68180-516-01); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD  21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA.",
      "product_quantity": "20,556 bottles",
      "reason_for_recall": "CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.",
      "recall_initiation_date": "20160406",
      "center_classification_date": "20160916",
      "termination_date": "20170807",
      "report_date": "20160928",
      "code_info": "Batch number: H303487, H303488, H303489, Exp 09/16",
      "more_code_info": ""
    }
  ]
}