{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Belle Plaine",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M014"
        ],
        "brand_name": [
          "CVS HEALTH EARWAX REMOVAL DROPS EARWAX REMOVAL AID",
          "CVS HEALTH EARWAX REMOVAL KIT"
        ],
        "generic_name": [
          "CARBAMIDE PEROXIDE"
        ],
        "manufacturer_name": [
          "CVS Pharmacy, Inc."
        ],
        "product_ndc": [
          "51316-822",
          "51316-823"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "CARBAMIDE PEROXIDE"
        ],
        "rxcui": [
          "702050"
        ],
        "spl_id": [
          "1ba4260c-f726-77de-e063-6294a90ab529",
          "52f5c6f4-95ea-d093-e063-6394a90a037c"
        ],
        "spl_set_id": [
          "42a22e06-1b66-4359-852c-7c39e1b3940a",
          "f842534c-46dd-42c7-8386-9a03ce16da86"
        ],
        "package_ndc": [
          "51316-822-00",
          "51316-823-00"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "31PZ2VAU81"
        ],
        "upc": [
          "0050428078273"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99278",
      "recalling_firm": "Bell Pharmaceuticals, Inc",
      "address_1": "200 W Beaver St",
      "address_2": "",
      "postal_code": "56011-1894",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S Nationwide",
      "recall_number": "D-0678-2026",
      "product_description": "CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe & Drops- NDC 51316-823-00.), Distributed by: CVS Pharmacy., Inc. One CVS Drive, Woonsocket, RI 02895,",
      "product_quantity": "106,301 units",
      "reason_for_recall": "SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).",
      "recall_initiation_date": "20260625",
      "center_classification_date": "20260714",
      "report_date": "20260722",
      "code_info": "Lot: a) 1505121, 1504242, exp 2027-03; 1505132, 1505182, 1505191, 1505291, 1505331, exp 2027-04; b) 1504231, 1504311, exp 2027-03; 1505312, 1505321, exp 2027-04.",
      "more_code_info": ""
    }
  ]
}