{
  "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": "2026-06-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Pennington",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA212693"
        ],
        "brand_name": [
          "ERYTHROMYCIN"
        ],
        "generic_name": [
          "ERYTHROMYCIN"
        ],
        "manufacturer_name": [
          "Zydus Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "70710-1047",
          "70710-1048"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ERYTHROMYCIN"
        ],
        "rxcui": [
          "197650",
          "598006"
        ],
        "spl_id": [
          "98d365a7-fc2c-4602-aef6-a604c82252c7"
        ],
        "spl_set_id": [
          "0277341c-8513-4317-9334-c242f97630c1"
        ],
        "package_ndc": [
          "70710-1047-3",
          "70710-1047-1",
          "70710-1047-5",
          "70710-1048-3",
          "70710-1048-1",
          "70710-1048-5"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000009982",
          "N0000175877",
          "N0000175935",
          "M0028311"
        ],
        "pharm_class_pe": [
          "Decreased Sebaceous Gland Activity [PE]"
        ],
        "pharm_class_epc": [
          "Macrolide [EPC]",
          "Macrolide Antimicrobial [EPC]"
        ],
        "pharm_class_cs": [
          "Macrolides [CS]"
        ],
        "unii": [
          "63937KV33D"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98870",
      "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 U.S",
      "recall_number": "D-0544-2026",
      "product_description": "Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; a) 30 count bottles (NDC 70710-1047-3); b) 100 count bottles (NDC 70710-1047-1).",
      "product_quantity": "23,880 bottles",
      "reason_for_recall": "CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit",
      "recall_initiation_date": "20260429",
      "center_classification_date": "20260520",
      "report_date": "20260527",
      "code_info": "Lots: a) M411146, Expires: 08/2026; M502098, M502097, Expires: 01/2027; b) M411145, Expires: 08/2026.",
      "more_code_info": ""
    }
  ]
}