{
  "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": "2026-05-06",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Columbus",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA090520"
        ],
        "brand_name": [
          "ALENDRONATE SODIUM"
        ],
        "generic_name": [
          "ALENDRONATE SODIUM"
        ],
        "manufacturer_name": [
          "Hikma Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "0054-0282"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ALENDRONATE SODIUM"
        ],
        "rxcui": [
          "904447"
        ],
        "spl_id": [
          "56e063a8-8c3d-4445-91fd-0c8806c2b127"
        ],
        "spl_set_id": [
          "c910bb05-279b-4ffa-a867-46f4a0853ed5"
        ],
        "package_ndc": [
          "0054-0282-59"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0300540282592"
        ],
        "unii": [
          "2UY4M2U3RA"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98744",
      "recalling_firm": "Hikma Pharmaceuticals USA INC",
      "address_1": "1809 Wilson Rd",
      "address_2": "",
      "postal_code": "43228-9579",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide.",
      "recall_number": "D-0526-2026",
      "product_description": "Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0282-59.",
      "product_quantity": "4 single dose 75 ml bottles",
      "reason_for_recall": "This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.",
      "recall_initiation_date": "20260407",
      "center_classification_date": "20260508",
      "report_date": "20260506",
      "code_info": "Lot # AC2040A, Exp Date: 04/2026",
      "more_code_info": ""
    }
  ]
}