{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Baltimore",
      "state": "MD",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA077626"
        ],
        "brand_name": [
          "RAMIPRIL"
        ],
        "generic_name": [
          "RAMIPRIL"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "68180-588",
          "68180-589",
          "68180-590",
          "68180-591"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "RAMIPRIL"
        ],
        "rxcui": [
          "198188",
          "198189",
          "261962",
          "845488"
        ],
        "spl_id": [
          "dfeb2e7a-ca24-4bfc-8d8d-01d2309b0c92"
        ],
        "spl_set_id": [
          "a8cdec12-81d1-4ef4-82c0-d05d93c37a07"
        ],
        "package_ndc": [
          "68180-589-09",
          "68180-589-10",
          "68180-589-01",
          "68180-589-02",
          "68180-590-09",
          "68180-590-10",
          "68180-590-01",
          "68180-590-02",
          "68180-591-09",
          "68180-591-10",
          "68180-591-02",
          "68180-591-01",
          "68180-588-01",
          "68180-588-02",
          "68180-588-09"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368180591092",
          "0368180589099",
          "0368180590095"
        ],
        "nui": [
          "N0000175562",
          "N0000000181"
        ],
        "pharm_class_epc": [
          "Angiotensin Converting Enzyme Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Angiotensin-converting Enzyme Inhibitors [MoA]"
        ],
        "unii": [
          "L35JN3I7SJ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "95610",
      "recalling_firm": "Lupin Pharmaceuticals Inc.",
      "address_1": "Harborplace Tower",
      "address_2": "111 S Calvert St Fl 21st",
      "postal_code": "21202-6174",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide.",
      "recall_number": "D-0053-2025",
      "product_description": "Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-590-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India",
      "product_quantity": "146,322 bottles",
      "reason_for_recall": "CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor",
      "recall_initiation_date": "20241023",
      "center_classification_date": "20241119",
      "termination_date": "20260105",
      "report_date": "20241127",
      "code_info": "a) NDC 68180-590-09;  Lots  G326928, exp. date 30-Sep-25,  GA00964, exp. date 31-Dec-25,   b) NDC 68180-590-01,  Lots  G326897, G326929, exp. date 30-Sep-25,  GA00854, GA00933, GA00954, exp. date 31-Dec-25,   c) NDC 68180-590-02,  Lot GA00955, exp. date 31-Dec-25"
    }
  ]
}