{
  "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 II",
      "openfda": {
        "application_number": [
          "ANDA206298"
        ],
        "brand_name": [
          "DICLOFENAC SODIUM"
        ],
        "generic_name": [
          "DICLOFENAC SODIUM"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "51672-1363"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DICLOFENAC SODIUM"
        ],
        "rxcui": [
          "855642"
        ],
        "spl_id": [
          "38ef9dc7-662f-056c-e063-6394a90a47e2"
        ],
        "spl_set_id": [
          "aa1e1ed3-0444-4bf5-a0ee-5d21a7fca391"
        ],
        "package_ndc": [
          "51672-1363-3",
          "51672-1363-7"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "QTG126297Q"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98351",
      "recalling_firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
      "address_1": "2 Independence Way",
      "address_2": "N/A",
      "postal_code": "08540-6620",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide.",
      "recall_number": "D-0342-2026",
      "product_description": "Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1363-7",
      "product_quantity": "N/A",
      "reason_for_recall": "Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.",
      "recall_initiation_date": "20260127",
      "center_classification_date": "20260223",
      "report_date": "20260211",
      "code_info": "Lot # AD92721, Exp Date: 3/31/2027."
    }
  ]
}