Bell Pharmaceuticals, Inc: Topcare Health, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 Ml) A) Kit - Washer Bulb & Drops Included

TopCare Health Carbamide Peroxide ear drops are being recalled nationwide because the product contains significantly less active ingredient than labeled (about 0.6% instead of the expected 6-7%) and has a lower pH than specified. The recall affects two product formats: a kit with a washer bulb and drops, and a single bottle version, distributed by Topco Associates. This is a Class II recall, meaning the product may not work as intended but is not expected to cause serious harm.

Recalling firm

Bell Pharmaceuticals, Inc

Product

TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800-835-34), DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007.

Reason

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Classification

Class II

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-06-25

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

U.S Nationwide

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/fe4d97d3-be17-413d-978b-efee2dc65afc