{
  "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": "Pulaski",
      "state": "TN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA209745"
        ],
        "brand_name": [
          "SILODOSIN"
        ],
        "generic_name": [
          "SILODOSIN"
        ],
        "manufacturer_name": [
          "AvKARE"
        ],
        "product_ndc": [
          "42291-777",
          "42291-778"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SILODOSIN"
        ],
        "rxcui": [
          "809477",
          "826612"
        ],
        "spl_id": [
          "4875ae6d-fc8a-e013-e063-6394a90a97f2"
        ],
        "spl_set_id": [
          "ea3bbafb-d32a-d0d3-e053-2a95a90ac387"
        ],
        "package_ndc": [
          "42291-777-30",
          "42291-778-90"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000000099",
          "N0000175553"
        ],
        "pharm_class_moa": [
          "Adrenergic alpha-Antagonists [MoA]"
        ],
        "pharm_class_epc": [
          "alpha-Adrenergic Blocker [EPC]"
        ],
        "unii": [
          "CUZ39LUY82"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96247",
      "recalling_firm": "AvKARE",
      "address_1": "615 N 1st St",
      "address_2": "N/A",
      "postal_code": "38478-2403",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA Nationwide",
      "recall_number": "D-0229-2025",
      "product_description": "Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN 38478, Manufactured by: Amneal Pharmaceuticals of NY, LLC, NY 11719, NDC 42291-778-90",
      "product_quantity": "1266 bottles",
      "reason_for_recall": "Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%)",
      "recall_initiation_date": "20250204",
      "center_classification_date": "20250220",
      "report_date": "20250226",
      "code_info": "Lot#: BC20223A, Exp. March 31, 2025."
    }
  ]
}