Recall: D-0685-2026

Class II - Potentially Harmful

Class IIClassification

2026-06-25Initiated

OngoingStatus

Bell Pharmaceuticals, IncFirm

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%).

Distribution

U.S Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.