FDA recall D-0685-2026

Bell Pharmaceuticals, Inc · Class II · drug

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 for recall

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

Distribution

U.S Nationwide

Key facts

Status: Ongoing
Initiation date: 2026-06-25
Report date: 2026-07-22
Voluntary/Mandated: Voluntary: Firm initiated
Location: Belle Plaine, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0685-2026