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Recalls & Safety AlertsVersion 8

FDA Records Ongoing Class II Recall of FAMILY Wellness Earwax Removal Kits

An FDA enforcement report lists 11,977 units of a carbamide peroxide 6.5% kit recalled nationwide as subpotent, with the action still ongoing.

By AI ReporterUpdated Aug 7, 2026, 9:48 a.m. ET
An FDA enforcement report, recall number , records an recall of FAMILY Wellness Carbamide Peroxide 6.5% earwax removal kits. The record lists the recalling firm as , gives the recall initiation date as June 25, 2026, and the report date as July 22, 2026. The quantity is listed as "" distributed U.S. nationwide. The status is listed as , and the record may be updated. The reason given in the enforcement report is a subpotent drug: low pH and a significantly reduced assay. The record states the figures as "(~0.6% vs expected ~6 7%)" — the expected value is written that way in the record, and the entry as published is not clear on it. The affected product is described in the record as FAMILY Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bulb Included, NDC 55319-835-01, distributed by Midwood Brands LLC, 500 Volvo Pkwy, Chesapeake, VA 23320. The lots listed are 1505124, 1505311 and 1505332, with an expiration date of April 2027. is the FDA's middle recall category, used where a product may cause temporary or medically reversible harm and where the probability of serious harm is remote, according to the agency's published recall definitions. The FDA's enforcement database records no other enforcement action by this firm — a point worth stating plainly, and one that says nothing about fault in this action. For readers wondering whether they have it: this is a finished over-the-counter consumer product bought off the shelf, sold as a store-brand kit containing a 0.5 fl oz (15 mL) squeeze-dropper bottle of liquid and a soft rubber "washer" bulb syringe, and listed with its own National Drug Code. The active ingredient, carbamide peroxide, also called urea hydrogen peroxide (CAS 124-43-6), is a manufactured white crystalline solid of urea and hydrogen peroxide that releases hydrogen peroxide when it dissolves; the remainder of the liquid is inactive ingredients typical of these formulations, such as glycerin, propylene glycol, citric acid, a surfactant and purified water, according to FDA-published labelling on DailyMed and the National Center for Biotechnology Information's PubChem entry. Labelling for products of this type describes the liquid being placed as drops in the ear, with the enclosed bulb syringe used afterwards to flush the ear canal gently with warm water. That background describes the product generally and says nothing about this recall.

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Revision history

  1. Version 87 Aug 2026, 13:48current

    No new facts; added headline and dek and left the verified record text unchanged.

  2. Version 77 Aug 2026, 13:20

    Removed product details not supported by the sourced reference data (retailer brand attribution, sodium citrate, application and foaming descriptions) and restated the ingredient and usage background as given by DailyMed and PubChem.

  3. Version 67 Aug 2026, 12:57current

    Added headline and dek; body unchanged from v5, source list unchanged.

  4. Version 57 Aug 2026, 12:43

    Added headline and dek, restored the labelling detail that the applicator tip does not enter the ear canal and that the foaming can crackle; source list unchanged in substance.

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