Recalls & Safety AlertsVersion 6

FDA Records Nationwide Class II Recall of 29,474 Units of Clinere Carbamide Peroxide

The agency's enforcement report cites a sub-potent drug with low pH and a significantly reduced assay; the recall is listed as ongoing.

By AI ReporterUpdated Aug 7, 2026, 10:23 a.m. ET

The U.S. Food and Drug Administration's enforcement report for recall number records an , nationwide recall of Clinere Carbamide Peroxide, initiated on June 25, 2026 and reported on July 22, 2026. The recalling firm is listed as ., and the quantity as 29,474 units. The matter is developing; the enforcement record lists the recall status as . The reason given in the record is a sub-potent drug: "low pH and significantly reduced assay (~0.6% vs expected ~6 7%)" — the expected figure is reproduced here as the record has it, and the record's wording on that point is unclear. The product is described in the record as Clinere Carbamide Peroxide, sold as (a) two bottles of 2 x 0.50 mL, 6.5%, 0.5 fl. oz. (15 mL) and (b) one bottle of 0.50 fl. oz. (15 mL), distributed by Quest Products LLC, Pleasant Prairie, WI 53158, NDC 68229-102-01. The affected lots are listed as (a) 1504241, exp 2027-03, and (b) 1504291 and 1504301, exp 2027-03. The FDA classified the action 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. By way of background, carbamide peroxide — also called urea hydrogen peroxide, hydrogen peroxide urea, UHP, Hyperol or percarbamide (CH6N2O3) — is a synthetic crystalline white solid formed as a complex of urea and hydrogen peroxide, and it releases hydrogen peroxide when it dissolves, according to a published U.S. patent document held by the USPTO. In products of this kind it is dissolved to a 6.5% strength in a liquid carrier and packaged in a small 15 mL (0.5 fl. oz.) bottle for topical application from a dropper. The recalled item is the consumer form: carbamide peroxide preparations are available without a prescription and the finished dropper bottles are bought off the shelf by ordinary shoppers, so those holding it are household purchasers rather than industrial buyers. This background describes the substance and the product category only 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.

Was this report accurate and useful?

Sources

Revision history

Version 67 Aug 2026, 14:23current
No new facts in the record; headline and dek added and text retained unchanged.
Version 57 Aug 2026, 12:25
Replaced the otic-monograph and DailyMed background with the sourced USPTO patent description of carbamide peroxide, and added the supporting source URLs.
Version 47 Aug 2026, 08:30
Rewrote the background paragraph to match the cited monograph and registry sources, removing label wording (earwax removal aid, age limits, bulb syringe flushing) not supported by the reference data, and added the missing source links.
Version 37 Aug 2026, 04:06
Quoted the assay wording exactly as the enforcement record has it rather than rendering the expected value as 6.7%, and replaced the PubChem-based background with the 21 CFR earwax removal aid definition and DailyMed label directions.
Version 26 Aug 2026, 23:40
Corrected the product-background paragraph to match the cited chemical and label references (removed the unsupported glycerin-base and OTC-monograph description) and added source attribution and URLs.

How we work

This site models an investigative reporter rather than a wire desk. The aim is the most complete, accurate and timely account we can assemble — all three, not a trade between them. Reports go out within minutes of the coverage they are built from, carrying context a newsroom would otherwise need a day and a records request to gather: what has happened at this place before, what the operator’s record is, which aircraft it actually was.

Reports are built from primary sources — accident and court records, official registries, weather observations, agency statements — and from reputable news organisations, each named where their reporting is used. Facts are extracted before anything is written, and every one must be supported by a quotation found in the source itself; the model that writes the report is given only those verified facts and never sees the article, so it cannot introduce a detail no source stated.

Where sources disagree we publish the disagreement, attributed, rather than picking a figure. Where a fact comes from a record rather than a reporter, we say so, and the language matches: an instrument reading is never described as something anyone confirmed. Some things are deliberately withheld — a suspect is not named until an agency names them on the record, victims until families or officials release them — and corrections appear as visible revisions, never as silent edits.

None of that makes a report true. A quotation check proves a source said something, not that it was right, and an automated system can be confidently wrong in ways the checks do not catch. If something here is wrong, the feedback above is how it gets found. The full methodology, including what we refuse to publish.