FDA-Drug2026-07-22Class IICHEMICAL
Audiologist's Choice Carbamide Peroxide recalled for subpotent active ingredient
What this means
Bell Pharmaceuticals distributed Audiologist's Choice Carbamide Peroxide ear cleaning solution with significantly reduced active ingredient—about 0.6% instead of the expected 6–7%—and abnormally low pH. This makes the product ineffective for its intended use.
- Check if you own Audiologist's Choice Carbamide Peroxide, lot 1505123 or 1505131 (both expire April 2027).
- Stop using the product and contact your audiologist or healthcare provider for guidance on safe alternatives.
- Return the product to where you purchased it or contact Bell Pharmaceuticals for instructions.
The agency's original wording
Hazard
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S Nationwide
Affected count
5,762 units
Manufactured in
200 W Beaver St, Belle Plaine, MN, United States
Products
AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb Included (NDC 59256-001-02); b) 1 bottle (NDC 59256-836-34), Distributed By: Oaktree Products Inc., St. Louis. MO 63005.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0682-2026More Bell Pharmaceuticals recalls
- FDA-Drug2026-07-22Foster & Thrive Carbamide Peroxide recalled for significantly reduced active ingredient
- FDA-Drug2026-07-22Good Neighbor Pharmacy Carbamide Peroxide 6.5% recalled for subpotent solution
- FDA-Drug2026-07-22CVS Health Carbamide Peroxide 6.5% recalled for subpotent formulation
- FDA-Drug2026-07-22TopCare Health Carbamide Peroxide 6.5% recalled for subpotent formula
- FDA-Drug2026-07-22CAREone Carbamide Peroxide 6.5% oral rinse recalled for subpotent active ingredient
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