{
  "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": "Completed",
      "city": "Naples",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA078466"
        ],
        "brand_name": [
          "AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE"
        ],
        "generic_name": [
          "AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "68180-459",
          "68180-755",
          "68180-756",
          "68180-472",
          "68180-463",
          "68180-473",
          "68180-759",
          "68180-760",
          "68180-757",
          "68180-758"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "AMLODIPINE BESYLATE",
          "BENAZEPRIL HYDROCHLORIDE"
        ],
        "rxcui": [
          "898342",
          "898346",
          "898350",
          "898353",
          "898356",
          "898359"
        ],
        "spl_id": [
          "53566d4f-ff40-4815-b922-3416cde56fb1"
        ],
        "spl_set_id": [
          "968c611b-43a7-40f0-9ed3-aa67ee88364b"
        ],
        "package_ndc": [
          "68180-755-01",
          "68180-755-02",
          "68180-755-03",
          "68180-756-01",
          "68180-756-02",
          "68180-756-03",
          "68180-459-01",
          "68180-459-02",
          "68180-459-03",
          "68180-472-01",
          "68180-472-02",
          "68180-472-03",
          "68180-463-01",
          "68180-463-02",
          "68180-463-03",
          "68180-473-01",
          "68180-473-02",
          "68180-473-03",
          "68180-759-01",
          "68180-759-02",
          "68180-759-03",
          "68180-760-01",
          "68180-760-02",
          "68180-760-03",
          "68180-757-01",
          "68180-757-02",
          "68180-757-03",
          "68180-758-01",
          "68180-758-02",
          "68180-758-03"
        ],
        "is_original_packager": [
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        ],
        "upc": [
          "0368180459019"
        ],
        "unii": [
          "N1SN99T69T",
          "864V2Q084H"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97182",
      "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": "Letter",
      "distribution_pattern": "Nationwide in the US",
      "recall_number": "D-0542-2025",
      "product_description": "Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL, 34108, United States, Manufactured by: Lupin Limited, Goa 103 722, INDIA, NDC 68180-755-01.",
      "product_quantity": "7668 bottles",
      "reason_for_recall": "Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027",
      "recall_initiation_date": "20250702",
      "center_classification_date": "20250728",
      "report_date": "20250806",
      "code_info": "Lot GB01616, expiration 2/28/2027",
      "more_code_info": ""
    }
  ]
}