{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA210393"
        ],
        "brand_name": [
          "TACROLIMUS"
        ],
        "generic_name": [
          "TACROLIMUS"
        ],
        "manufacturer_name": [
          "Glenmark Pharmaceuticals Inc., USA"
        ],
        "product_ndc": [
          "68462-534",
          "68462-881"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "TACROLIMUS"
        ],
        "rxcui": [
          "313189",
          "314266"
        ],
        "spl_id": [
          "15dcd504-ee3e-4f0f-a765-55e31511641e"
        ],
        "spl_set_id": [
          "c2d2e3a1-f346-4245-b445-6dd44e371180"
        ],
        "package_ndc": [
          "68462-534-35",
          "68462-534-65",
          "68462-534-94",
          "68462-881-35",
          "68462-881-65",
          "68462-881-94"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368462534946",
          "0368462881941"
        ],
        "unii": [
          "WM0HAQ4WNM"
        ]
      },
      "product_type": "Drugs",
      "event_id": "90550",
      "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 in the USA",
      "recall_number": "D-1304-2022",
      "product_description": "Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35, b) 60 g tube, NDC 68462-534-65, c) 100 g tube, NDC 68462-534-94, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India.",
      "product_quantity": "654,756 tubes",
      "reason_for_recall": "Defective Container: Tube split from side seam",
      "recall_initiation_date": "20220711",
      "center_classification_date": "20220804",
      "report_date": "20220810",
      "code_info": "Lot #s:   a) 15200058, 15200066, 15200067, Exp 06/2022; 15200075, Exp 07/2022; 15200094, Exp 08/2022; 15200119, 15200120, 15200122, Exp 09/2022; 15200131, 15200132, Exp 10/2022; 15200133, 15200134, 15200136, 15200139, Exp 11/2022; 15210033, 15210035, 15210036, 15210038 Exp 01/2023; 15210092, 15210094, 15210097, 15210099, Exp 03/2023; 15210100, 15210101, 15210104, Exp 04/2023; 15210122, Exp 05/2023; 15210148, 15210149, 15210153, 15210155, 15210157, 15210158, Exp 06/2023; 15210173, 15210174, 15210176, 15210177, 15210178, 15210179, Exp 07/2023; 15210184, 15210186, Exp 08/2023; 15210214,  Exp 09/2023; 15210225, 15210226, 15210228, 15210230, 15210231, Exp 10/2023; 15220001, 15220002, Exp 12/2023.    b) 15200092, Exp 08/2022; 15200114, 15200115, Exp 09/2022; 15200123, 15200124, Exp 10/2022; 15200142, 15200144, Exp 11/2022; 15210014, 15210015, 15210021, Exp 12/2022; 15210031, Exp 01/2023; 15210055, Exp 02/2023; 15210073, 15210075, Exp 03/2023; 15210117, 15210118, Exp 04/2023; 15210144, 15210147, 15210160, 15210162, Exp 06/2023; 15210171, Exp 07/2023; 15210187, 15210190, 15210191, 15210193, Exp 08/2023; 15210212, Exp 09/2023; 15210244, 15210247, Exp 11/2023; 15220007, Exp 12/2023; 15220019, 15220028, Exp 01/2024; 15220032, 15220034, 15220053, Exp 02/2024; 15220062, 15220064, 15220072, Exp 03/2024.    c) 15200065, Exp 06/2022; 15200108, 15200109, Exp 09/2022; 15200125, Exp 10/2022; 15200148, 15200149, 15200150, Exp 11/2022; 15210007, 15210009, 15210012, 15210018, Exp 12/2022; 15210049, Exp 02/2023; 15210076, 15210077, 15210089, Exp 03/2023; 15210112, 15210114, Exp 04/2023; 15210124, 15210125, 15210127, Exp 05/2023; 15210169, 15210170, Exp 07/2023; 15210196, 15210199, Exp 08/2023; 15210204, 15210206, 15210207, 15210210, Exp 09/2023; 15210248, Exp 11/2023; 15220004, 15220013, 15220014, 15220015, Exp 12/2023; 15220025, 15220026, Exp 01/2024."
    }
  ]
}