{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA075576"
        ],
        "brand_name": [
          "OMEPRAZOLE"
        ],
        "generic_name": [
          "OMEPRAZOLE"
        ],
        "manufacturer_name": [
          "Quallent Pharmaceuticals Health LLC"
        ],
        "product_ndc": [
          "82009-022"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "OMEPRAZOLE"
        ],
        "rxcui": [
          "198051"
        ],
        "spl_id": [
          "17380ad5-9506-8e44-aa84-b6ce52ac7b9b"
        ],
        "spl_set_id": [
          "665e9877-85ac-fdb6-54ac-1c47941ceab8"
        ],
        "package_ndc": [
          "82009-022-10"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175525",
          "N0000000147",
          "N0000182140"
        ],
        "pharm_class_epc": [
          "Proton Pump Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Proton Pump Inhibitors [MoA]",
          "Cytochrome P450 2C19 Inhibitors [MoA]"
        ],
        "unii": [
          "KG60484QX9"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97161",
      "recalling_firm": "Dr. Reddy's Laboratories, Inc.",
      "address_1": "107 College Rd E",
      "address_2": "N/A",
      "postal_code": "08540-6623",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA Nationwide",
      "recall_number": "D-0525-2025",
      "product_description": "Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Manufactured for: Qualient Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands, NDC 82009-022-10.  NDC 82009-022-10",
      "product_quantity": "1476 bottles",
      "reason_for_recall": "Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.",
      "recall_initiation_date": "20250630",
      "center_classification_date": "20250714",
      "report_date": "20250723",
      "code_info": "Lot: C2403017, Exp 12/31/2026"
    }
  ]
}