{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Mahwah",
      "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": [
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        ],
        "upc": [
          "0368462626528"
        ],
        "nui": [
          "N0000008841",
          "N0000009982"
        ],
        "pharm_class_pe": [
          "Decreased Protein Synthesis [PE]",
          "Decreased Sebaceous Gland Activity [PE]"
        ],
        "unii": [
          "F2VW3D43YT"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97619",
      "recalling_firm": "Glenmark Pharmaceuticals Inc., USA",
      "address_1": "750 Corporate Dr",
      "address_2": "N/A",
      "postal_code": "07430-2009",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0662-2025",
      "product_description": "Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-626-52",
      "product_quantity": "13824 tubes",
      "reason_for_recall": "CGMP Deviations: Market complaints received for gritty texture (grainy)",
      "recall_initiation_date": "20250917",
      "center_classification_date": "20250924",
      "report_date": "20251001",
      "code_info": "Batch # 19252524, Exp Date: May 2027",
      "more_code_info": ""
    }
  ]
}