{
  "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": "2026-09-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Columbus",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA077900"
        ],
        "brand_name": [
          "RAMIPRIL"
        ],
        "generic_name": [
          "RAMIPRIL"
        ],
        "manufacturer_name": [
          "Exelan Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "76282-670",
          "76282-671",
          "76282-672",
          "76282-673"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "RAMIPRIL"
        ],
        "rxcui": [
          "198188",
          "198189",
          "261962",
          "845488"
        ],
        "spl_id": [
          "37481fc5-771f-4dc7-aa06-6913ab75d485"
        ],
        "spl_set_id": [
          "1e1dfacf-b831-4743-a874-9a5e5ef8a120"
        ],
        "package_ndc": [
          "76282-670-01",
          "76282-671-01",
          "76282-671-05",
          "76282-672-01",
          "76282-672-05",
          "76282-673-01",
          "76282-673-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0376282670010",
          "0376282672014",
          "0376282673011"
        ],
        "nui": [
          "N0000175562",
          "N0000000181"
        ],
        "pharm_class_epc": [
          "Angiotensin Converting Enzyme Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Angiotensin-converting Enzyme Inhibitors [MoA]"
        ],
        "unii": [
          "L35JN3I7SJ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99711",
      "recalling_firm": "Hikma Pharmaceuticals USA INC.",
      "address_1": "1809 Wilson Rd",
      "address_2": "N/A",
      "postal_code": "43228-9579",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0831-2026",
      "product_description": "Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33432, Manufactured by: West-Ward Columbus Inc., Columbus, OH  43228.",
      "product_quantity": "a) 25,970 bottles; b) 2,384 bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).",
      "recall_initiation_date": "20260824",
      "center_classification_date": "20260903",
      "report_date": "20260902",
      "code_info": "a) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027"
    }
  ]
}