Recall D-0685-2026

US Class II Ongoing · initiated 2026-06-25

Recalling firm

Bell Pharmaceuticals, Inc, MN

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%).

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