{
  "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": "East Brunswick",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA040668"
        ],
        "brand_name": [
          "CYPROHEPTADINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "CYPROHEPTADINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Rising Pharma Holdings, Inc."
        ],
        "product_ndc": [
          "64980-504"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CYPROHEPTADINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "866021"
        ],
        "spl_id": [
          "9b4845c1-9b59-4809-9247-50565fc4b6fb"
        ],
        "spl_set_id": [
          "e2bf4d46-6585-41d9-868c-98603b165d5b"
        ],
        "package_ndc": [
          "64980-504-48"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0364980504485"
        ],
        "unii": [
          "NJ82J0F8QC"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99401",
      "recalling_firm": "Rising Pharma Holding, Inc.",
      "address_1": "2 Tower Center Blvd Ste 1401",
      "address_2": "N/A",
      "postal_code": "08816-1149",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide U.S.A.",
      "recall_number": "D-0724-2026",
      "product_description": "Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ, Manufactured by: Lyne Laboratories, Inc., Brockton, MA. NDC 64980-504-48.",
      "product_quantity": "74208 units",
      "reason_for_recall": "Presence of Precipitate: medication was crystallizing and particles floating in the bottle",
      "recall_initiation_date": "20260713",
      "center_classification_date": "20260723",
      "report_date": "20260729",
      "code_info": "Lots: Batch # CR2518, Exp. 11/2027; Batch # CR2601, Exp. 12/2027; CR2602, CR2603, Exp. 01/2028; CR2604, CR2605, Exp. 02/2028."
    }
  ]
}