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

Recall Summary TopCare Health Carbamide Peroxide ear drops (0.5 FL OZ bottles) are being recalled because the product is significantly weaker than intended—containing only about 0.6% active ingredient instead of the expected 6-7%—and has an abnormally low pH. The affected products were distributed nationwide by Topco Associates LLC and sold under NDC numbers 36800-835-33 and 36800-835-34.

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/da36b1b9-6d66-4095-9ba5-666ef1a78ae6