{
  "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": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA212317"
        ],
        "brand_name": [
          "DILTIAZEM HYDROCHLORIDE"
        ],
        "generic_name": [
          "DILTIAZEM HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "GLENMARK PHARMACEUTICALS INC., USA"
        ],
        "product_ndc": [
          "68462-562",
          "68462-850",
          "68462-851"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DILTIAZEM HYDROCHLORIDE"
        ],
        "rxcui": [
          "830865",
          "830869",
          "830872"
        ],
        "spl_id": [
          "42982c30-aae0-4fa3-983c-500bd75b028c"
        ],
        "spl_set_id": [
          "fb1606ea-1cff-46fd-b8e5-8135da76436c"
        ],
        "package_ndc": [
          "68462-850-01",
          "68462-851-01",
          "68462-562-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368462562017",
          "0368462851012",
          "0368462850015"
        ],
        "unii": [
          "OLH94387TE"
        ]
      },
      "product_type": "Drugs",
      "event_id": "95660",
      "recalling_firm": "Glenmark Pharmaceuticals Inc., USA",
      "address_1": "750 Corporate Dr",
      "address_2": "",
      "postal_code": "07430-2009",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0094-2025",
      "product_description": "Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules, Manufactured for : Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-851-01.",
      "product_quantity": "12,864 bottles",
      "reason_for_recall": "cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.",
      "recall_initiation_date": "20241101",
      "center_classification_date": "20241203",
      "report_date": "20241211",
      "code_info": "Lot #s 17222452, Exp. Date, 11/30/2024; 17230607, Exp. Date 02/28/2025",
      "more_code_info": ""
    }
  ]
}