{
  "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": "2026-08-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "East Windsor",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA040319"
        ],
        "brand_name": [
          "DICYCLOMINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "DICYCLOMINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Aurobindo Pharma Limited"
        ],
        "product_ndc": [
          "59651-719"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DICYCLOMINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "991061"
        ],
        "spl_id": [
          "ec746016-eed0-4e37-bb9c-cb430c8a7f07"
        ],
        "spl_set_id": [
          "ec746016-eed0-4e37-bb9c-cb430c8a7f07"
        ],
        "package_ndc": [
          "59651-719-01",
          "59651-719-99"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0359651719015"
        ],
        "unii": [
          "CQ903KQA31"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99492",
      "recalling_firm": "Aurobindo Pharma USA Inc",
      "address_1": "279 Princeton Hightstown Rd",
      "address_2": "",
      "postal_code": "08520-1401",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide.",
      "recall_number": "D-0733-2026",
      "product_description": "Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-719-99",
      "product_quantity": "6,408 bottles distributed to market",
      "reason_for_recall": "shortfill; reports of empty capsules.",
      "recall_initiation_date": "20260723",
      "center_classification_date": "20260804",
      "report_date": "20260812",
      "code_info": "Batch # DMC125018A, Exp Date: 07/2027.",
      "more_code_info": ""
    }
  ]
}