{
  "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": "2026-07-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Parsippany",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA071745"
        ],
        "brand_name": [
          "PRAZOSIN HYDROCHLORIDE"
        ],
        "generic_name": [
          "PRAZOSIN HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Teva Pharmaceuticals USA, Inc."
        ],
        "product_ndc": [
          "0093-4067",
          "0093-4068",
          "0093-4069"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PRAZOSIN HYDROCHLORIDE"
        ],
        "rxcui": [
          "198141",
          "312593",
          "312594"
        ],
        "spl_id": [
          "b9dbf961-8602-4533-90ad-8e5cf16e6649"
        ],
        "spl_set_id": [
          "7293cef3-ef9e-40dc-9995-875ef047f693"
        ],
        "package_ndc": [
          "0093-4067-01",
          "0093-4067-10",
          "0093-4068-01",
          "0093-4068-10",
          "0093-4069-01",
          "0093-4069-52",
          "0093-4069-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0300934068016",
          "0300934069013",
          "0300934067019"
        ],
        "unii": [
          "X0Z7454B90"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97755",
      "recalling_firm": "Teva Pharmaceuticals USA, Inc",
      "address_1": "400 Interpace Pkwy Bldg A",
      "address_2": "N/A",
      "postal_code": "07054-1120",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide",
      "recall_number": "D-0105-2026",
      "product_description": "Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4068-01, b) 1000 Capsules, NDC 0093-4068-10",
      "product_quantity": "291,512 bottles",
      "reason_for_recall": "CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.",
      "recall_initiation_date": "20251007",
      "center_classification_date": "20251024",
      "report_date": "20251105",
      "code_info": "a) NDC 0093-4068-01: Lot # 3010398A, 3010399A, 3010400A, 3010401A, 3010353A, Exp Date: 12/2025; Lot # 3010439A, 3010388A, Exp Date: 01/2026; Lot # 3010526A, 3010527A, Exp Date: 03/2026; Lot # 3010591A, 07/2026; Lot # 3010343A, Exp Date: 10/2025; Lot # 3010352A, Exp Date: 11/2025; Lot # 3010468A, 3010469A, 3010461A, Exp Date: 02/2026; Lot # 3010629A, Exp Date:  09/2026; Lot # 3010653A, Exp Date: 01/2027; Lot # 3010654A, 3010679A, 3010702A, Exp Date: 02/2027; Lot # 3010547A, Exp Date: 04/2026  b) NDC 0093-4068-10: Lot # 3010402A Exp Date: 02/2028; Lot # 3010593A, Exp Date: 07/2026, Lot # 3010610A, Exp Date: 09/2026"
    }
  ]
}