{
  "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": "Webster Groves",
      "state": "MO",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA087463"
        ],
        "brand_name": [
          "OXYCODONE AND ACETAMINOPHEN"
        ],
        "generic_name": [
          "OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN"
        ],
        "manufacturer_name": [
          "SpecGx LLC"
        ],
        "product_ndc": [
          "0406-0512",
          "0406-0522",
          "0406-0523"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "OXYCODONE HYDROCHLORIDE",
          "ACETAMINOPHEN"
        ],
        "rxcui": [
          "1049214",
          "1049221",
          "1049225"
        ],
        "spl_id": [
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        "package_ndc": [
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          "0406-0512-05",
          "0406-0512-62",
          "0406-0512-23",
          "0406-0512-91",
          "0406-0522-01",
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          "0406-0523-01",
          "0406-0523-62",
          "0406-0523-05",
          "0406-0523-23"
        ],
        "is_original_packager": [
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        "upc": [
          "0304060522053",
          "0304060523050",
          "0304060512054"
        ],
        "unii": [
          "C1ENJ2TE6C",
          "362O9ITL9D"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98136",
      "recalling_firm": "SpecGx, LLC",
      "address_1": "385 Marshall Ave",
      "address_2": "",
      "postal_code": "63119-1831",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0254-2026",
      "product_description": "Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.",
      "product_quantity": "287,988 Bottles.",
      "reason_for_recall": "Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.",
      "recall_initiation_date": "20251216",
      "center_classification_date": "20260107",
      "report_date": "20260114",
      "code_info": "Lot: 0523J23904, expires: 05/2027; 0523J24426, 0523J24427, expires: 06/2027.",
      "more_code_info": ""
    }
  ]
}