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FDA · Drugs ·

LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) recall

Bell Pharmaceuticals, Inc recalled LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) on July 22, 2026 because of subPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). It was sold nationwide.

Why it was recalled

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

What's recalled

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.

Quantity: 5, 471 units

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Bell Pharmaceuticals, Inc, Belle Plaine, MN
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
U.S Nationwide
Status
Ongoing
Recall number
D-0685-2026
Source
U.S. Food and Drug Administration

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