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Recalls & Safety AlertsVersion 6

FDA Lists Class II Recall of 1,201 Bottles of CAREone Carbamide Peroxide 6.5%

An ongoing nationwide recall of a single lot "Lot:1505141", "exp 2027-04." cites a sub-potent drug with low pH and a significantly reduced assay, according to the agency's enforcement record.

By AI ReporterUpdated Aug 7, 2026, 10:28 a.m. ET
An FDA enforcement report, recall number , lists an nationwide recall of CAREone Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL) bottles, NDC 72476-838-34, distributed by Foodhold U.S.A, LLC of Landover, MD. The recalling firm is listed as . The record gives the reason as a sub-potent drug, with low pH and a significantly reduced assay; the entry states the figure as "(~0.6% vs expected ~6 7%)", and the expected value as written in the record is unclear. The record identifies the affected stock by two codes, printed here exactly as the enforcement entry gives them: - **Lot:1505141** - **exp 2027-04.** The recall covers . Anyone holding a bottle can check the lot number and expiry printed on the container against those two codes. According to the same record, the recall was initiated on June 25, 2026 and reported on July 22, 2026, and its status is . The FDA has classified it as o a product may cause temporary or medically reversible harm and where the chance of serious harm is remote he FFDA's published recall definitions. This is a developing enforcement action and the entry may be updated. By way of background on the product itself: carbamide peroxide, also called urea hydrogen peroxide, percarbamide or hyperol, is a manufactured white crystalline solid, formula CH6N2O3, made by combining urea with hydrogen peroxide into a single crystalline complex rather than extracted from a plant or animal source, according to a European Commission Scientific Committees glossary entry, a Wikidata chemical entry and background description in U.S. Patent 11,975,023 published by the USPTO. Those sources describe it as inexpensive and readily available in bulk. The recalled item is not the raw crystal but a liquid preparation containing 6.5% carbamide peroxide, packaged in a 15 mL (0.5 fl oz) dropper-style bottle and supplied over the counter, without a prescription, for external application. CAREone is a supermarket own-brand line, so this is a small retail bottle of the kind found in the pharmacy and personal-care aisle and picked up by ordinary shoppers, not a bulk ingredient shipped to manufacturers. That background describes the compound and the product generally and says nothing about this recall. The FDA's enforcement database records no other enforcement action by this firm. That is context only and says nothing about fault in this action.

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Revision history

  1. Version 67 Aug 2026, 14:28current

    Both identifying codes from the enforcement record are now printed verbatim ("Lot:1505141" and "exp 2027-04.") in a dedicated list high in the story and in the dek, replacing the earlier paraphrase "Lot 1505141, expiry 2027-04"; added a line telling readers to match the codes printed on their bottle. Quantity, dates, classification, reason wording, attribution to the FDA enforcement record and all background material and caveats are unchanged.

  2. Version 57 Aug 2026, 13:40

    Replaced the product background with the revised reference sources (European Commission, Wikidata, USPTO), dropped the unsupported hydrogen-peroxide-by-weight figure and the ear-drops characterisation, and described the item as an over-the-counter dropper bottle for external application.

  3. Version 47 Aug 2026, 08:36

    Added chemical reference attribution (Wikidata, GreenFacts, HandWiki) and the 35% hydrogen peroxide by weight and dropper/ear-drop format detail; headline and dek sharpened.

  4. Version 37 Aug 2026, 03:54

    Quoted the assay wording exactly as the FDA record states it rather than rendering the expected value as 6.7%, and removed product details (glycerin base, drop-dispensing bottle) not supported by the sources.

  5. Version 26 Aug 2026, 23:46

    Replaced the product-background paragraph with a chemistry- and packaging-based description sourced to USPTO patent 11,975,023, dropping the earlier monograph/earwax-aid framing.

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