{
  "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": "2026-06-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Bridgewater",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA040866"
        ],
        "brand_name": [
          "PRIMIDONE"
        ],
        "generic_name": [
          "PRIMIDONE"
        ],
        "manufacturer_name": [
          "Amneal Pharmaceuticals of New York LLC"
        ],
        "product_ndc": [
          "53746-544",
          "53746-545"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PRIMIDONE"
        ],
        "rxcui": [
          "96304",
          "198150"
        ],
        "spl_id": [
          "574c0bff-04c5-41f0-8d10-315a824d8efd"
        ],
        "spl_set_id": [
          "3cdc361a-5558-4341-ad40-f8bc29b4f1ce"
        ],
        "package_ndc": [
          "53746-544-01",
          "53746-544-10",
          "53746-544-05",
          "53746-545-01",
          "53746-545-10",
          "53746-545-05"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175753",
          "N0000008486"
        ],
        "pharm_class_epc": [
          "Anti-epileptic Agent [EPC]"
        ],
        "pharm_class_pe": [
          "Decreased Central Nervous System Disorganized Electrical Activity [PE]"
        ],
        "unii": [
          "13AFD7670Q"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99146",
      "recalling_firm": "Amneal Pharmaceuticals, LLC",
      "address_1": "400 Crossing Blvd Fl 3",
      "address_2": "N/A",
      "postal_code": "08807-2863",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the USA.",
      "recall_number": "D-0585-2026",
      "product_description": "Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA.  Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.  NDC: 53746-544-01",
      "product_quantity": "27,936 100-count bottles",
      "reason_for_recall": "Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.",
      "recall_initiation_date": "20260603",
      "center_classification_date": "20260610",
      "report_date": "20260617",
      "code_info": "Lot AM251676, EXP 11/31/2028"
    }
  ]
}