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Recalls & Safety AlertsVersion 6

FDA Records Nationwide Class II Recall of QC Quality Choice Carbamide Peroxide Drops

An FDA enforcement report lists 15,843 units of the 6.5% ear drops recalled by Bell Pharmaceuticals, Inc for reduced potency; the action is ongoing.

By AI ReporterUpdated Aug 7, 2026, 9:34 a.m. ET
An FDA enforcement report, recall number , records a nationwide recall of QC Quality Choice Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL), initiated by on June 25, 2026 and reported on July 22, 2026. The record lists the reason as "SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%)" — the expected figure appears in the record with a space and is reproduced here as written. The quantity is given in the record as "." The status is listed as , and this remains a developing action. The enforcement report describes the affected product in two configurations: a) with a washer bulb included (NDC 63868-026-15), lots 1505121 and 1505342, exp 2027-04; and b) a single bottle (NDC 63868-027-16), lot 1505381, exp 2027-04. The product is listed as distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376, with distribution given as U.S. nationwide. For readers wondering whether they would have this on a shelf: carbamide peroxide, also called urea hydrogen peroxide or percarbamide (formula CH6N2O3), is a white crystalline hydrogen peroxide–urea complex made by combining urea with hydrogen peroxide, according to background description in US Patent 11,975,023. The recalled item is not the raw chemical but a finished, non-prescription consumer preparation — a 6.5% solution in a 15 mL (0.5 fl oz) bottle, sold under a store brand, in one version with a soft rubber washer bulb included for flushing with water and in another as the bottle alone. It is the kind of item bought off drugstore and supermarket shelves, so the holders are ordinary shoppers rather than manufacturers. This is background about the product type and says nothing about this recall. The FDA classified the recall as . By the agency's own definition, is its middle category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote. The agency's enforcement database records no other enforcement action by this firm — a matter of record that says nothing about fault in this action.

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Revision history

  1. Version 67 Aug 2026, 13:34current

    Trimmed unsourced product-use description (ear-canal flushing, tooth-whitening) to match the reference data exactly; added headline and dek.

  2. Version 57 Aug 2026, 13:14

    Added headline and standfirst; no change to the underlying FDA record, which still lists the recall as ongoing.

  3. Version 47 Aug 2026, 08:47

    Replaced the product-background paragraph with a chemistry- and packaging-based description sourced to US Patent 11,975,023, and added that source to the citations.

  4. Version 37 Aug 2026, 04:03

    Added a paragraph explaining what the product is and how it is normally sold, and quoted the quantity as the record words it.

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