{
  "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": "2026-06-24",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Elmwood Park",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA091634"
        ],
        "brand_name": [
          "ALYACEN 1/35"
        ],
        "generic_name": [
          "NORETHINDRONE AND ETHINYL ESTRADIOL"
        ],
        "manufacturer_name": [
          "Glenmark Pharmaceuticals Inc., USA"
        ],
        "product_ndc": [
          "68462-394",
          "68462-556"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "rxcui": [
          "310463",
          "312033",
          "392662",
          "748797",
          "749852",
          "749858",
          "1242786",
          "1242787"
        ],
        "spl_id": [
          "9d4967e6-42df-4468-99a6-9b57499497d9"
        ],
        "spl_set_id": [
          "5c02b4d3-1e2f-439a-ae45-02304ee190d1"
        ],
        "package_ndc": [
          "68462-556-84",
          "68462-556-29",
          "68462-394-84",
          "68462-394-29"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368462394847",
          "0368462394298",
          "0368462556849"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99101",
      "recalling_firm": "Glenmark Pharmaceuticals Inc., USA",
      "address_1": "619 River Dr",
      "address_2": "",
      "postal_code": "07407-1317",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA Nationwide.",
      "recall_number": "D-0588-2026",
      "product_description": "Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister Cards each containing 28 tablets, 28 day regimen, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430, NDC 68462-556-29",
      "product_quantity": "",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.",
      "recall_initiation_date": "20260527",
      "center_classification_date": "20260612",
      "report_date": "20260624",
      "code_info": "Lot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027",
      "more_code_info": ""
    }
  ]
}