{
  "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": "2026-05-06",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Parsippany",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA076356"
        ],
        "brand_name": [
          "CLARAVIS"
        ],
        "generic_name": [
          "ISOTRETINOIN"
        ],
        "manufacturer_name": [
          "Teva Pharmaceuticals USA, Inc."
        ],
        "product_ndc": [
          "0555-1054",
          "0555-1055",
          "0555-1056",
          "0555-1057"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ISOTRETINOIN"
        ],
        "rxcui": [
          "197843",
          "197844",
          "197845",
          "403930",
          "404059",
          "404062",
          "404065",
          "643488"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
          "a31fd109-d0fd-4ab9-ba98-a3d64333c18d"
        ],
        "package_ndc": [
          "0555-1054-60",
          "0555-1054-86",
          "0555-1054-56",
          "0555-1055-60",
          "0555-1055-86",
          "0555-1055-56",
          "0555-1056-60",
          "0555-1056-86",
          "0555-1057-60",
          "0555-1057-56",
          "0555-1057-86"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175607",
          "M0018962"
        ],
        "pharm_class_epc": [
          "Retinoid [EPC]"
        ],
        "pharm_class_cs": [
          "Retinoids [CS]"
        ],
        "unii": [
          "EH28UP18IF"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98730",
      "recalling_firm": "Teva Pharmaceuticals USA, Inc",
      "address_1": "400 Interpace Pkwy Bldg A",
      "address_2": "N/A",
      "postal_code": "07054-1120",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA, Puerto Rico and Virgin Islands",
      "recall_number": "D-0521-2026",
      "product_description": "Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.",
      "product_quantity": "5,101 cartons",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin",
      "recall_initiation_date": "20260406",
      "center_classification_date": "20260506",
      "report_date": "20260429",
      "code_info": "Lots#: 100067507, 100067508, Exp 07/31/2026",
      "more_code_info": ""
    }
  ]
}