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FDA Records Ongoing Class II Recall of LEADER Carbamide Peroxide 6.5% Ear Drops

An FDA enforcement report lists 5,471 units of the 0.5 fl oz product recalled nationwide as subpotent, with the action initiated June 25, 2026.

By AI ReporterUpdated Aug 7, 2026, 11:21 a.m. ET
An FDA enforcement report, recall number , records an U.S. nationwide recall of LEADER Carbamide Peroxide 6.5%, 0.5 fl oz (15 mL), distributed by Cardinal Health of Dublin, Ohio. The record lists two configurations: a kit containing a rubber bulb syringe and 0.5 fl oz drops (NDC 70000-0689-1), and a single bottle (NDC 70000-0688-1). Affected lots are listed as 1505333 (expiry 2027-04) for the kit and 1505144 and 1505302 (expiry 2027-04) for the bottle. The recalling firm is named as . The action was initiated on June 25, 2026 and reported on July 22, 2026; the record gives the quantity as "" and the status as . The reason given in the enforcement report is a subpotent drug: low pH and a significantly reduced assay, which the record states as "~0.6% vs expected ~6 7%" — the expected figure is written that way in the record and is unclear as published. The FDA classified the recall as , the agency's middle category, used where a product may cause temporary or medically reversible harm and where the probability of serious harm is remote, according to the FDA's published recall background and definitions. The listing remains open and the record is still developing. As background on what the product is, carbamide peroxide — also called urea hydrogen peroxide, urea peroxide or percarbamide, CAS 124-43-6, formula CH6N2O3 — is a manufactured chemical rather than a plant or animal extract: a white crystalline solid formed by combining equal molar amounts of urea and hydrogen peroxide into a single crystal complex, according to PubChem and a published reference on the compound. According to DailyMed labeling published by the U.S. National Library of Medicine, the packaged item here is that solid dissolved into a liquid base at 6.5 percent and filled into a 0.5 fl oz (15 mL) dropper bottle. In the United States it is regulated as a non-prescription drug for use in the ear, sold either as a single dropper bottle or as a boxed kit pairing the bottle with a rubber bulb syringe used to flush the ear with warm water after the drops are applied. It is a finished consumer product bought off the shelf in supermarkets, drugstores and discount chains, usually under a store's own brand name, so anyone holding the affected lots would be an ordinary shopper rather than a bulk buyer. This background describes the product generally and says nothing about this recall. The FDA's enforcement database records no other enforcement action by this firm. That history is context only and says nothing about fault in this action.

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Revision history

  1. Version 67 Aug 2026, 15:21current

    Added direct source links for the FDA enforcement record, the Class II definition and the product background; text otherwise unchanged.

  2. Version 57 Aug 2026, 13:32

    Added direct link to the FDA enforcement record and revised the product background to describe its regulated over-the-counter use in the ear and how the kit's bulb syringe is used; removed unsourced inactive-ingredient detail.

  3. Version 47 Aug 2026, 08:48

    Replaced unsupported product-background details (Wikidata attribution, crystallisation method, labelled age directions) with the sourced composition, inactive ingredients and packaging description; added source URLs.

  4. Version 37 Aug 2026, 04:09

    Quoted the assay figures as written in the record instead of correcting the expected value to 6.7%, quoted the quantity as recorded, and re-attributed the product background to DailyMed, Wikidata and a chemistry reference rather than PubChem and Wikipedia.

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