{
  "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": "Ongoing",
      "city": "Naples",
      "state": "FL",
      "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": [
          "E7199S1YWR",
          "0J48LPH2TH"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97118",
      "recalling_firm": "Lupin Pharmaceuticals Inc.",
      "address_1": "5801 Pelican Bay Blvd",
      "address_2": "Suite 500",
      "postal_code": "34108-2755",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "N/A",
      "distribution_pattern": "Product was distributed nationwide within the United States.",
      "recall_number": "D-0532-2025",
      "product_description": "Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only,  Mfg for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, Manufactured by: Lupin Limited Nagpur-441 108, INDIA, NDC 68180-519-01",
      "product_quantity": "58,968 bottles",
      "reason_for_recall": "Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.",
      "recall_initiation_date": "20250620",
      "center_classification_date": "20250717",
      "report_date": "20250723",
      "code_info": "Lot #: QA01081, Exp. Date April 2027"
    }
  ]
}