FDA-Drug2026-07-22Class IICHEMICAL

Audiologist's Choice Carbamide Peroxide recalled for subpotent active ingredient

LABEL MIX UPNationwide distributionDrugs

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-0682-2026

More Bell Pharmaceuticals recalls

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