{
  "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": "Terminated",
      "city": "Pennington",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA090174"
        ],
        "brand_name": [
          "VENLAFAXINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "VENLAFAXINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Zydus Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "68382-034",
          "68382-035",
          "68382-036"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "VENLAFAXINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "313581",
          "313583",
          "313585"
        ],
        "spl_id": [
          "8c02c121-fe14-45f5-b2bc-b09fd377531f"
        ],
        "spl_set_id": [
          "5351fe67-17d9-42ec-9e8b-6585fdb9e29e"
        ],
        "package_ndc": [
          "68382-034-06",
          "68382-034-16",
          "68382-034-10",
          "68382-035-06",
          "68382-035-16",
          "68382-035-10",
          "68382-036-06",
          "68382-036-16",
          "68382-036-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368382034106",
          "0368382035103",
          "0368382036100"
        ],
        "unii": [
          "7D7RX5A8MO"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94850",
      "recalling_firm": "Zydus Pharmaceuticals (USA) Inc",
      "address_1": "73 Route 31 N",
      "address_2": "",
      "postal_code": "08534-3601",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0617-2024",
      "product_description": "Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and b)1000-count bottles (NDC 68382-034-10), Rx only, Mfg. by: Zydus Lifesciences Ltd. Ahmedabad, India;  Dist. by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534",
      "product_quantity": "a) 13,128 bottles; b) 252 bottles",
      "reason_for_recall": "Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.",
      "recall_initiation_date": "20240621",
      "center_classification_date": "20240723",
      "termination_date": "20250806",
      "report_date": "20240731",
      "code_info": "Lot #: a) M213175, Exp. Date 09/2024; b) M213176, Exp. Date 09/2024",
      "more_code_info": ""
    }
  ]
}