{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA090492"
        ],
        "brand_name": [
          "DILTIAZEM HYDROCHLORIDE"
        ],
        "generic_name": [
          "DILTIAZEM HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "47335-675",
          "47335-676",
          "47335-677",
          "47335-678",
          "47335-679"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DILTIAZEM HYDROCHLORIDE"
        ],
        "rxcui": [
          "830795",
          "830801",
          "830837",
          "830845",
          "830861"
        ],
        "spl_id": [
          "3c94f868-93d3-4b36-8420-b2903a0bd79a"
        ],
        "spl_set_id": [
          "6f71ba5e-7bd6-409a-80c6-2f22d975aefc"
        ],
        "package_ndc": [
          "47335-675-83",
          "47335-675-81",
          "47335-675-19",
          "47335-675-13",
          "47335-675-18",
          "47335-676-83",
          "47335-676-81",
          "47335-676-19",
          "47335-676-13",
          "47335-676-18",
          "47335-677-83",
          "47335-677-81",
          "47335-677-19",
          "47335-677-13",
          "47335-677-18",
          "47335-678-83",
          "47335-678-81",
          "47335-678-19",
          "47335-678-13",
          "47335-678-18",
          "47335-679-83",
          "47335-679-81",
          "47335-679-19",
          "47335-679-13",
          "47335-679-18"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0347335679830",
          "0347335677836",
          "0347335676839",
          "0347335678833",
          "0347335675832"
        ],
        "unii": [
          "OLH94387TE"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91500",
      "recalling_firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
      "address_1": "2 Independence Way",
      "address_2": "N/A",
      "postal_code": "08540-6620",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the U.S.",
      "recall_number": "D-0262-2023",
      "product_description": "Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg; Rx only; 90-count bottles, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 47335-679-81",
      "product_quantity": "Lot # HAC3120A: 6912 Bottles; Lot # HAC3121A: 6792 Bottles; Lot # HAC4460A: 6816 Bottles; Lot # HAD0365A: 6744 Bottles; Lot # HAD1452A: 6840 Bottles",
      "reason_for_recall": "Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.",
      "recall_initiation_date": "20230113",
      "center_classification_date": "20230202",
      "termination_date": "20231027",
      "report_date": "20230208",
      "code_info": "Lot #: HAC3120A, HAC3121A, Exp. 04/2023; HAC4460A, Exp. 10/2023; HAD0365A, Exp. 12/2023; HAD1452A, Exp. 02/2024."
    }
  ]
}