{
  "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": "2026-08-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Elmwood Park",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA204637"
        ],
        "brand_name": [
          "AZELAIC ACID"
        ],
        "generic_name": [
          "AZELAIC ACID"
        ],
        "manufacturer_name": [
          "Glenmark Pharmaceuticals Inc., USA"
        ],
        "product_ndc": [
          "68462-626"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "AZELAIC ACID"
        ],
        "rxcui": [
          "1041518"
        ],
        "spl_id": [
          "28cca0c1-2f38-4fa2-8aaf-d3c8978b0fc6"
        ],
        "spl_set_id": [
          "0b5ab22e-c78a-4429-9a76-a4ba2d11fcde"
        ],
        "package_ndc": [
          "68462-626-52"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368462626528"
        ],
        "nui": [
          "N0000008841",
          "N0000009982"
        ],
        "pharm_class_pe": [
          "Decreased Protein Synthesis [PE]",
          "Decreased Sebaceous Gland Activity [PE]"
        ],
        "unii": [
          "F2VW3D43YT"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99490",
      "recalling_firm": "Glenmark Pharmaceuticals Inc., USA",
      "address_1": "619 River Dr",
      "address_2": "N/A",
      "postal_code": "07407-1317",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Nationwide within the United States.",
      "recall_number": "D-0731-2026",
      "product_description": "Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52.",
      "product_quantity": "N/A",
      "reason_for_recall": "CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.",
      "recall_initiation_date": "20260723",
      "center_classification_date": "20260728",
      "report_date": "20260805",
      "code_info": "Lot #: 19260937A, Exp. Date February 2028; 19261225A, 19261185A, Exp. Date March 2028; 19261664A, 19261682A, Exp. Date April 2028."
    }
  ]
}