{
  "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": "Ongoing",
      "city": "Pennington",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA217656"
        ],
        "brand_name": [
          "ICOSAPENT ETHYL"
        ],
        "generic_name": [
          "ICOSAPENT ETHYL"
        ],
        "manufacturer_name": [
          "Zydus Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "70710-1592",
          "70710-1738"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ICOSAPENT ETHYL"
        ],
        "rxcui": [
          "1304979",
          "1811180"
        ],
        "spl_id": [
          "fc13bee2-0828-4bc5-b967-b47e368f0a24"
        ],
        "spl_set_id": [
          "5910742b-c5e6-4029-9a19-97669e3808bc"
        ],
        "package_ndc": [
          "70710-1738-4",
          "70710-1592-7"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0370710159276"
        ],
        "unii": [
          "6GC8A4PAYH"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98560",
      "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 in the USA",
      "recall_number": "D-0400-2026",
      "product_description": "Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534.  NDC: 70710-1592-7",
      "product_quantity": "60,541 bottles",
      "reason_for_recall": "Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.",
      "recall_initiation_date": "20260309",
      "center_classification_date": "20260320",
      "report_date": "20260318",
      "code_info": "Lot #: S2520249, S2520250, S2520267, Exp. Date 2027/Jan; S2520303, S2520305, S2520332, Exp. Date 2027/Feb; S2540208, S2540209, Exp. Date 2027/Apr"
    }
  ]
}