{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Parsippany",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA210221"
        ],
        "brand_name": [
          "CEPHALEXIN"
        ],
        "generic_name": [
          "CEPHALEXIN"
        ],
        "manufacturer_name": [
          "Ascend Laboratories, LLC"
        ],
        "product_ndc": [
          "67877-544",
          "67877-545"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CEPHALEXIN"
        ],
        "rxcui": [
          "309110",
          "309113"
        ],
        "spl_id": [
          "84f07b4a-a15e-41cb-af85-e110c5cf342e"
        ],
        "spl_set_id": [
          "bb28751c-bd1b-4e7f-8271-a14c1b4314e3"
        ],
        "package_ndc": [
          "67877-544-88",
          "67877-544-68",
          "67877-545-88",
          "67877-545-68"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "OBN7UDS42Y"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96912",
      "recalling_firm": "Ascend Laboratories, LLC",
      "address_1": "339 Jefferson Rd Ste 101",
      "address_2": "",
      "postal_code": "07054-3707",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA.",
      "recall_number": "D-0469-2025",
      "product_description": "Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-68",
      "product_quantity": "10,620 - 200 mL bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis.    The individual impurity was identified to be Cephalexin Glucose Adduct.",
      "recall_initiation_date": "20250523",
      "center_classification_date": "20250612",
      "report_date": "20250618",
      "code_info": "Lot #: 23142343, Exp Date: 6/30/2025; 23143526, Exp Date: 9/30/2025; 23144036, Exp Date: 10/31/2025; 23144269, Exp Date: 11/30/2025; Lot 24140027, Exp Date: 12/31/2025; 24144282, Exp Date: 10/31/2026",
      "more_code_info": ""
    }
  ]
}