{
  "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": "2026-09-23",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Not Yet Classified",
      "openfda": {
        "application_number": [
          "ANDA064022"
        ],
        "brand_name": [
          "NYSTATIN"
        ],
        "generic_name": [
          "NYSTATIN"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "51672-1289"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "NYSTATIN"
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        "rxcui": [
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        "spl_id": [
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        "package_ndc": [
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          "51672-1289-2"
        ],
        "is_original_packager": [
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        ],
        "nui": [
          "N0000175498",
          "M0017172"
        ],
        "pharm_class_epc": [
          "Polyene Antifungal [EPC]"
        ],
        "pharm_class_cs": [
          "Polyenes [CS]"
        ],
        "unii": [
          "BDF1O1C72E"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99876",
      "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": "N/A",
      "distribution_pattern": "U.S. Nationwide.",
      "recall_number": "N/A",
      "product_description": "Nystatin Cream, USP, 15 g per tube, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761; Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532.  NDC: 51672-1289-1",
      "product_quantity": "N/A",
      "reason_for_recall": "Failed Stability Specifications",
      "recall_initiation_date": "20260914",
      "report_date": "20260923",
      "code_info": "LOT AD49605, LOT AD49606; Exp. 05/31/2027",
      "more_code_info": ""
    }
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}