{
  "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": "Warren",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA205710"
        ],
        "brand_name": [
          "BUDESONIDE"
        ],
        "generic_name": [
          "BUDESONIDE"
        ],
        "manufacturer_name": [
          "Cipla USA Inc."
        ],
        "product_ndc": [
          "69097-318",
          "69097-319",
          "69097-321"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "BUDESONIDE"
        ],
        "rxcui": [
          "252559",
          "349094",
          "351109"
        ],
        "spl_id": [
          "29644146-4bcf-49d0-80b3-e31f4b3a6f54"
        ],
        "spl_set_id": [
          "c52c5382-1400-44b9-95be-a30e1cf706da"
        ],
        "package_ndc": [
          "69097-318-86",
          "69097-318-87",
          "69097-318-32",
          "69097-318-53",
          "69097-319-86",
          "69097-319-87",
          "69097-319-32",
          "69097-319-53",
          "69097-321-86",
          "69097-321-87",
          "69097-321-32",
          "69097-321-53"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "Q3OKS62Q6X"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97170",
      "recalling_firm": "Cipla USA, Inc.",
      "address_1": "10 Independence Blvd",
      "address_2": "N/A",
      "postal_code": "07059-2730",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed Nationwide in the USA",
      "recall_number": "D-0541-2025",
      "product_description": "Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd. Indore SEZ, Pithampur, India. Manufactured for: Ciple USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC# 69097-319-86 (pouch), 69097-319-87 (carton)",
      "product_quantity": "13,680 ampoules",
      "reason_for_recall": "Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.",
      "recall_initiation_date": "20250630",
      "center_classification_date": "20250722",
      "report_date": "20250730",
      "code_info": "Batch # 4IA0505, Exp 09/31/2026"
    }
  ]
}