{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Baltimore",
      "state": "MD",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA077912"
        ],
        "brand_name": [
          "LISINOPRIL AND HYDROCHLOROTHIAZIDE"
        ],
        "generic_name": [
          "LISINOPRIL AND HYDROCHLOROTHIAZIDE"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "68180-518",
          "68180-519",
          "68180-520"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "HYDROCHLOROTHIAZIDE",
          "LISINOPRIL"
        ],
        "rxcui": [
          "197885",
          "197886",
          "197887"
        ],
        "spl_id": [
          "4035482a-7e09-464f-ae01-a8a75fc3c4c1"
        ],
        "spl_set_id": [
          "515f735c-5dba-43d9-8a58-97a319cafd56"
        ],
        "package_ndc": [
          "68180-518-02",
          "68180-518-01",
          "68180-518-30",
          "68180-519-30",
          "68180-519-01",
          "68180-519-02",
          "68180-520-02",
          "68180-520-30",
          "68180-520-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368180519010",
          "0368180518013",
          "0368180520016"
        ],
        "nui": [
          "N0000175359",
          "N0000175419",
          "M0471776"
        ],
        "pharm_class_pe": [
          "Increased Diuresis [PE]"
        ],
        "pharm_class_epc": [
          "Thiazide Diuretic [EPC]"
        ],
        "pharm_class_cs": [
          "Thiazides [CS]"
        ],
        "unii": [
          "0J48LPH2TH",
          "E7199S1YWR"
        ]
      },
      "product_type": "Drugs",
      "event_id": "83354",
      "recalling_firm": "Lupin Pharmaceuticals Inc.",
      "address_1": "111 S Calvert St Fl 21ST",
      "address_2": "N/A",
      "postal_code": "21202-6174",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed to wholesalers/distributors and supermarket and drug chains throughout the United States.",
      "recall_number": "D-1720-2019",
      "product_description": "Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle, Rx only, Manufactured by for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by: Lupin Limited, Pithampur, INDIA NDC 68180-518-01",
      "product_quantity": "39,216 bottles",
      "reason_for_recall": "Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles.",
      "recall_initiation_date": "20190717",
      "center_classification_date": "20190809",
      "termination_date": "20200914",
      "report_date": "20190821",
      "code_info": "Batch# H900575, exp. date 01/2022"
    }
  ]
}