{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Brookhaven",
      "state": "NY",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA207792"
        ],
        "brand_name": [
          "ISOTRETINOIN"
        ],
        "generic_name": [
          "ISOTRETINOIN"
        ],
        "manufacturer_name": [
          "Amneal Pharmaceuticals NY LLC"
        ],
        "product_ndc": [
          "69238-1017",
          "69238-1174",
          "69238-1175",
          "69238-1176"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ISOTRETINOIN"
        ],
        "rxcui": [
          "197843",
          "197844",
          "197845",
          "403930"
        ],
        "spl_id": [
          "c2645360-e4a8-4737-9065-3dbbd4b6e6b7"
        ],
        "spl_set_id": [
          "c2917c3d-3499-48a0-ba53-120cb979195d"
        ],
        "package_ndc": [
          "69238-1174-1",
          "69238-1174-3",
          "69238-1175-1",
          "69238-1175-3",
          "69238-1017-1",
          "69238-1017-3",
          "69238-1176-1",
          "69238-1176-3"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0369238117530",
          "0369238117615",
          "0369238117639",
          "0369238117417",
          "0369238117516",
          "0369238117431",
          "0369238101737",
          "0369238101713"
        ],
        "nui": [
          "N0000175607",
          "M0018962"
        ],
        "pharm_class_epc": [
          "Retinoid [EPC]"
        ],
        "pharm_class_cs": [
          "Retinoids [CS]"
        ],
        "unii": [
          "EH28UP18IF"
        ]
      },
      "product_type": "Drugs",
      "event_id": "84073",
      "recalling_firm": "Amneal Pharmaceuticals, Inc.",
      "address_1": "50 Horseblock Rd",
      "address_2": "N/A",
      "postal_code": "11719-9509",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Recalled product was distributed to retailers and wholesalers who may have further distribute the product.",
      "recall_number": "D-0321-2020",
      "product_description": "Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1174-3",
      "product_quantity": "2460 cartons/3 blister cards/10 capsules each",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.",
      "recall_initiation_date": "20191016",
      "center_classification_date": "20191113",
      "termination_date": "20201109",
      "report_date": "20191120",
      "code_info": "Batch Numbers: BL10917, BL11017,  BL11117, Exp. date 11/2019"
    }
  ]
}