{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Hawthorne",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA086724"
        ],
        "brand_name": [
          "LIDOCAINE"
        ],
        "generic_name": [
          "LIDOCAINE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "51672-3008"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "LIDOCAINE"
        ],
        "rxcui": [
          "1543069"
        ],
        "spl_id": [
          "5353eb70-1eeb-5479-e063-6394a90a2e2b"
        ],
        "spl_set_id": [
          "5eb2c62f-5352-41d7-bd66-c65b1988a9ab"
        ],
        "package_ndc": [
          "51672-3008-5",
          "51672-3008-3"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175682",
          "M0000897",
          "N0000175426",
          "N0000175976"
        ],
        "pharm_class_epc": [
          "Amide Local Anesthetic [EPC]",
          "Antiarrhythmic [EPC]"
        ],
        "pharm_class_cs": [
          "Amides [CS]"
        ],
        "pharm_class_pe": [
          "Local Anesthesia [PE]"
        ],
        "unii": [
          "98PI200987"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99794",
      "recalling_firm": "SUN PHARMA /TARO",
      "address_1": "3 Skyline Dr",
      "address_2": "N/A",
      "postal_code": "10532-2174",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0848-2026",
      "product_description": "Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, L6T1C, Canada, Dist By: Taro Pharmaceuticals U.S.A. Inc. Hawthorne NY 70532 NDC: 51672-3008-5",
      "product_quantity": "65,328 50g jars",
      "reason_for_recall": "Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).",
      "recall_initiation_date": "20260831",
      "center_classification_date": "20260915",
      "report_date": "20260923",
      "code_info": "Lot # AD48154, Exp: 4/30/2027.",
      "more_code_info": ""
    }
  ]
}