{
  "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": "Completed",
      "city": "Pennington",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA077653"
        ],
        "brand_name": [
          "VENLAFAXINE"
        ],
        "generic_name": [
          "VENLAFAXINE"
        ],
        "manufacturer_name": [
          "Zydus Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "68382-018",
          "68382-019",
          "68382-020",
          "68382-021",
          "68382-101"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "VENLAFAXINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "313580",
          "313582",
          "313584",
          "313586",
          "314277"
        ],
        "spl_id": [
          "ea404f6c-7e07-4779-a52c-8cffb92718ef"
        ],
        "spl_set_id": [
          "72efad5f-0909-46a5-aa13-ac24fe015fe6"
        ],
        "package_ndc": [
          "68382-018-06",
          "68382-018-14",
          "68382-018-16",
          "68382-018-01",
          "68382-018-05",
          "68382-018-10",
          "68382-019-06",
          "68382-019-14",
          "68382-019-16",
          "68382-019-01",
          "68382-019-05",
          "68382-019-10",
          "68382-020-06",
          "68382-020-14",
          "68382-020-16",
          "68382-020-01",
          "68382-020-05",
          "68382-020-10",
          "68382-021-06",
          "68382-021-14",
          "68382-021-16",
          "68382-021-01",
          "68382-021-05",
          "68382-021-10",
          "68382-101-06",
          "68382-101-14",
          "68382-101-16",
          "68382-101-01",
          "68382-101-05",
          "68382-101-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368382019011",
          "0368382018014",
          "0368382021014",
          "0368382101013"
        ],
        "unii": [
          "7D7RX5A8MO"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96553",
      "recalling_firm": "Zydus Pharmaceuticals (USA) Inc",
      "address_1": "73 Route 31 N",
      "address_2": "N/A",
      "postal_code": "08534-3601",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide.",
      "recall_number": "D-0310-2025",
      "product_description": "Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-021-01.",
      "product_quantity": "13,128 100-Count Bottles",
      "reason_for_recall": "Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.",
      "recall_initiation_date": "20250321",
      "center_classification_date": "20250404",
      "report_date": "20250416",
      "code_info": "Lot #: M314265, Exp.: 31 October 2025."
    }
  ]
}