{
  "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": "2026-07-08",
    "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"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
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        "package_ndc": [
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          "70710-1592-7"
        ],
        "is_original_packager": [
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        "upc": [
          "0370710159276"
        ],
        "unii": [
          "6GC8A4PAYH"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96964",
      "recalling_firm": "Zydus Pharmaceuticals (USA) Inc",
      "address_1": "73 Route 31 N",
      "address_2": "",
      "postal_code": "08534-3601",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "IL, PA, & MS",
      "recall_number": "D-0497-2025",
      "product_description": "Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza, Italy, Distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-7.",
      "product_quantity": "11,616 bottles",
      "reason_for_recall": "Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.",
      "recall_initiation_date": "20250530",
      "center_classification_date": "20250630",
      "report_date": "20250618",
      "code_info": "Lot #s: B237040, B237041, Exp 10/31/2025",
      "more_code_info": ""
    }
  ]
}