{
  "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": "2026-06-03",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Mumbai",
      "state": "",
      "country": "India",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA218531"
        ],
        "brand_name": [
          "ENALAPRIL MALEATE"
        ],
        "generic_name": [
          "ENALAPRIL MALEATE"
        ],
        "manufacturer_name": [
          "Rising Pharma Holdings, Inc."
        ],
        "product_ndc": [
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          "64980-686",
          "64980-687",
          "64980-688"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
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        ],
        "substance_name": [
          "ENALAPRIL MALEATE"
        ],
        "rxcui": [
          "858804",
          "858810",
          "858813",
          "858817"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
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        "package_ndc": [
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          "64980-685-10",
          "64980-686-01",
          "64980-686-10",
          "64980-687-01",
          "64980-687-10",
          "64980-688-01",
          "64980-688-10"
        ],
        "is_original_packager": [
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        ],
        "unii": [
          "9O25354EPJ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98794",
      "recalling_firm": "JB Chemicals and Pharmaceuticals Ltd",
      "address_1": "Neelam Centre A Wing A B Wing",
      "address_2": "4th Floor; Hind Cycle Road",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0520-2026",
      "product_description": "Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 64980-688-10.",
      "product_quantity": "675 bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test",
      "recall_initiation_date": "20260423",
      "center_classification_date": "20260505",
      "report_date": "20260513",
      "code_info": "Lot #: GEH25023, Expires: 6/30/2027",
      "more_code_info": ""
    }
  ]
}