{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Minneapolis",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA201291"
        ],
        "brand_name": [
          "TROSPIUM CHLORIDE"
        ],
        "generic_name": [
          "TROSPIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "Padagis US LLC"
        ],
        "product_ndc": [
          "0574-0118"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TROSPIUM CHLORIDE"
        ],
        "rxcui": [
          "857564"
        ],
        "spl_id": [
          "d3a1d06a-74e4-40db-890f-046078da9ad2"
        ],
        "spl_set_id": [
          "4574f905-a8c5-4732-b934-d1c7f9e708c9"
        ],
        "package_ndc": [
          "0574-0118-30"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "1E6682427E"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93345",
      "recalling_firm": "Padagis US LLC",
      "address_1": "3940 Quebec Ave N",
      "address_2": "",
      "postal_code": "55427-1244",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0139-2024",
      "product_description": "Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured By:  Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun-248 197 Uttarakhand, India Distributed By: Padagis, Allegan, MI 49010.  NDC: 0574-0118-30",
      "product_quantity": "7,032 bottles",
      "reason_for_recall": "Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules",
      "recall_initiation_date": "20231101",
      "center_classification_date": "20231205",
      "report_date": "20231213",
      "code_info": "Lot: 231104, 231105, 231106, exp 7/31/2025",
      "more_code_info": ""
    }
  ]
}