{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Pennington",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA078226"
        ],
        "brand_name": [
          "AMLODIPINE BESYLATE"
        ],
        "generic_name": [
          "AMLODIPINE BESYLATE"
        ],
        "manufacturer_name": [
          "Zydus Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "68382-121",
          "68382-122",
          "68382-123"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "AMLODIPINE BESYLATE"
        ],
        "rxcui": [
          "197361",
          "308135",
          "308136"
        ],
        "spl_id": [
          "cd7a7360-2639-480a-af3d-0cb410c22110"
        ],
        "spl_set_id": [
          "fda0739d-b355-478c-acae-8f773a3ec4b3"
        ],
        "package_ndc": [
          "68382-121-01",
          "68382-121-05",
          "68382-121-16",
          "68382-121-77",
          "68382-122-16",
          "68382-122-01",
          "68382-122-05",
          "68382-122-77",
          "68382-123-16",
          "68382-123-01",
          "68382-123-05",
          "68382-123-77"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "864V2Q084H"
        ]
      },
      "product_type": "Drugs",
      "event_id": "69676",
      "recalling_firm": "Zydus Pharmaceuticals USA Inc",
      "address_1": "73 Route 31 N",
      "address_2": "N/A",
      "postal_code": "08534-3601",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0257-2015",
      "product_description": "Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-123-16",
      "product_quantity": "15,144 bottles",
      "reason_for_recall": "Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.",
      "recall_initiation_date": "20141001",
      "center_classification_date": "20141121",
      "termination_date": "20160226",
      "report_date": "20141203",
      "code_info": "Lot #: MP4344, Exp 04/2016",
      "more_code_info": ""
    }
  ]
}