{
  "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": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA206880"
        ],
        "brand_name": [
          "LEVETIRACETAM"
        ],
        "generic_name": [
          "LEVETIRACETAM INJECTION"
        ],
        "manufacturer_name": [
          "Dr.Reddy's Laboratories Inc"
        ],
        "product_ndc": [
          "43598-635",
          "43598-636",
          "43598-637"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "LEVETIRACETAM"
        ],
        "rxcui": [
          "1193358",
          "1193360",
          "1193362"
        ],
        "spl_id": [
          "f5cfc6e1-79f3-bd25-5f66-9ea05bc47def"
        ],
        "spl_set_id": [
          "0a9234b7-46b1-8e6c-a992-90f86cfb6e00"
        ],
        "package_ndc": [
          "43598-635-52",
          "43598-635-10",
          "43598-636-52",
          "43598-636-10",
          "43598-637-52",
          "43598-637-10"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000008486"
        ],
        "pharm_class_pe": [
          "Decreased Central Nervous System Disorganized Electrical Activity [PE]"
        ],
        "unii": [
          "44YRR34555"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96470",
      "recalling_firm": "Dr. Reddy's Laboratories, Inc.",
      "address_1": "107 College Rd E",
      "address_2": "",
      "postal_code": "08540-6623",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0365-2025",
      "product_description": "Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland Pharma Limited, Hyderabad, - 500 043 INDIA, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-636-52",
      "product_quantity": "4,010 bags",
      "reason_for_recall": "LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.",
      "recall_initiation_date": "20250313",
      "center_classification_date": "20250416",
      "report_date": "20250423",
      "code_info": "Lot: A1540076, Exp 08/31/2026",
      "more_code_info": ""
    }
  ]
}