{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "East Windsor",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA206906"
        ],
        "brand_name": [
          "AMLODIPINE AND OLMESARTAN MEDOXOMIL"
        ],
        "generic_name": [
          "AMLODIPINE AND OLMESARTAN MEDOXOMIL"
        ],
        "manufacturer_name": [
          "Aurobindo Pharma Limited"
        ],
        "product_ndc": [
          "65862-854",
          "65862-855",
          "65862-856",
          "65862-857"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "AMLODIPINE BESYLATE",
          "OLMESARTAN MEDOXOMIL"
        ],
        "rxcui": [
          "730861",
          "730866",
          "730869",
          "730872"
        ],
        "spl_id": [
          "4879a01c-0ba7-4d27-9847-f22e8546fa8f"
        ],
        "spl_set_id": [
          "b13a8b46-104e-4b75-8f4a-928d2204eff5"
        ],
        "package_ndc": [
          "65862-854-30",
          "65862-855-30",
          "65862-856-30",
          "65862-857-30"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0365862855305",
          "0365862856302",
          "0365862854308",
          "0365862857309"
        ],
        "unii": [
          "6M97XTV3HD",
          "864V2Q084H"
        ]
      },
      "product_type": "Drugs",
      "event_id": "81703",
      "recalling_firm": "Aurobindo Pharma USA Inc.",
      "address_1": "279 Princeton Hightstown Rd",
      "address_2": "N/A",
      "postal_code": "08520-1401",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S.A. Nationwide",
      "recall_number": "D-0289-2019",
      "product_description": "Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 0852 Made in India, NDC 65862-855-30",
      "product_quantity": "4464 bottles",
      "reason_for_recall": "Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream (peach).",
      "recall_initiation_date": "20181130",
      "center_classification_date": "20181206",
      "termination_date": "20220201",
      "report_date": "20181212",
      "code_info": "Lot#: OWSA18002-A, Exp 7/2020"
    }
  ]
}