Bell Pharmaceuticals, Inc: Leader, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 Ml), A) Kit -1 Rubber Bulb Syringe, 0.5 Fl Oz Drops

Recall Summary Bell Pharmaceuticals is recalling LEADER Carbamide Peroxide 6.5% ear drops sold nationwide because the product contains significantly less active ingredient than labeled (about 0.6% instead of 6-7%) and has an improper pH level, making it ineffective. The recall affects two versions: a kit with a rubber bulb syringe and a single bottle, both distributed by Cardinal Health. This is a Class II recall, meaning the product could cause temporary adverse health effects or pose a serious health hazard.

Recalling firm

Bell Pharmaceuticals, Inc

Product

LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS, (NDC 70000-0689-1); b) 1 bottle (NDC 70000-0688-1), DIST. BY CARDINAL HEALTH, DUBLIN, OH 43017.

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/e53c32ba-5ace-409f-aa3c-62b7d45eb008