FDA-Drug2026-07-22Class IICHEMICAL
Audiologist's Choice Carbamide Peroxide recalled for subpotent active ingredient
LABEL MIX UPNationwide distribution
Audiologist's Choice Carbamide Peroxide recalled for low potency
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.
Hazard
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
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, Inc recalls
- FDA-Drug2026-07-22Clinere Carbamide Peroxide recalled for subpotent formulation
- FDA-Drug2026-07-22Bell Pharmaceuticals FAMILY Wellness Carbamide Peroxide recalled for subpotent drug—significantly reduced active ingredient
- FDA-Drug2026-07-22QC Quality Choice Carbamide Peroxide oral rinse recalled for subpotent active ingredient
- FDA-Drug2026-07-22Leader Carbamide Peroxide 6.5% recalled for subpotent drug — significantly reduced active ingredient
- FDA-Drug2026-07-22Meijer Carbamide Peroxide 6.5% oral rinse recalled for subpotent drug — significantly reduced active ingredient
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