{
  "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": "Terminated",
      "city": "Baltimore",
      "state": "MD",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA078043"
        ],
        "brand_name": [
          "AMLODIPINE BESYLATE"
        ],
        "generic_name": [
          "AMLODIPINE BESYLATE"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "68180-233",
          "68180-750",
          "68180-751",
          "68180-752",
          "68180-719",
          "68180-720",
          "68180-721",
          "68180-455"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "AMLODIPINE BESYLATE"
        ],
        "rxcui": [
          "197361",
          "308135",
          "308136"
        ],
        "spl_id": [
          "cc27c9a5-dd2e-4a79-af00-28f51408362a"
        ],
        "spl_set_id": [
          "003dd1ec-16f8-4f96-b6a8-c4689d35892a"
        ],
        "package_ndc": [
          "68180-750-09",
          "68180-751-09",
          "68180-751-03",
          "68180-751-17",
          "68180-752-09",
          "68180-752-03",
          "68180-719-03",
          "68180-719-09",
          "68180-720-09",
          "68180-720-03",
          "68180-721-03",
          "68180-721-09",
          "68180-233-01",
          "68180-233-02",
          "68180-455-02",
          "68180-455-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368180233022"
        ],
        "unii": [
          "864V2Q084H"
        ]
      },
      "product_type": "Drugs",
      "event_id": "92618",
      "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 directly to three distributors in TN and NJ. Product may have been further distributed throughout the United States.",
      "recall_number": "D-0899-2023",
      "product_description": "Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 U.S, Manufactured by: Lupin Limited, Aurangabad 431 210 India, NDC 68180-721-03",
      "product_quantity": "3,096 bottles",
      "reason_for_recall": "Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.",
      "recall_initiation_date": "20230627",
      "center_classification_date": "20230707",
      "termination_date": "20240312",
      "report_date": "20230719",
      "code_info": "Lot #: A102887, Exp. 6/2023",
      "more_code_info": ""
    }
  ]
}