{
  "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": "Bedminster",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA203269"
        ],
        "brand_name": [
          "RIZATRIPTAN BENZOATE"
        ],
        "generic_name": [
          "RIZATRIPTAN BENZOATE"
        ],
        "manufacturer_name": [
          "Ascend Laboratories, LLC"
        ],
        "product_ndc": [
          "67877-261",
          "67877-262"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "RIZATRIPTAN BENZOATE"
        ],
        "rxcui": [
          "312840",
          "314209"
        ],
        "spl_id": [
          "9fd3ccaa-ae93-475b-9591-5c4af70f51c5"
        ],
        "spl_set_id": [
          "07e66554-bc85-4853-9f40-1249617630a9"
        ],
        "package_ndc": [
          "67877-261-30",
          "67877-261-01",
          "67877-261-05",
          "67877-261-18",
          "67877-261-25",
          "67877-262-30",
          "67877-262-01",
          "67877-262-05",
          "67877-262-18",
          "67877-262-25"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0367877261300"
        ],
        "unii": [
          "WR978S7QHH"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96770",
      "recalling_firm": "Ascend Laboratories, LLC",
      "address_1": "135 Us Highway 202 206 Ste 15",
      "address_2": "N/A",
      "postal_code": "07921-2608",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "US Nationwide.",
      "recall_number": "D-0533-2025",
      "product_description": "Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-261-18",
      "product_quantity": "N/A",
      "reason_for_recall": "CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.",
      "recall_initiation_date": "20250709",
      "center_classification_date": "20250717",
      "report_date": "20250723",
      "code_info": "Lot 23142117, 23142119, 23142122, Exp Date: May 2026; Lot 24142625, Exp Date: Jun. 2027"
    }
  ]
}