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FDAClass II

TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS I… Recalled: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL)… was recalled on June 25, 2026 in cooperation with the U.S. Food and Drug Administration because subPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%)..

Is my unit affected?

TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800-835-34), DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007.

Model, lot & date codes to check

Lot: a) 1505122, 1505343, expires: 2027-04; b) 1505142, 1505341, expires: 2027-04.

Units affected: 16,156 units

Where it was sold: U.S Nationwide

Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.

What's the hazard?

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

Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.

Your remedy & how to claim it

Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.

Contact: Recalling firm: Bell Pharmaceuticals, Inc

Not sure what you're entitled to? Read our guide: what to do if your product is recalled.

Official recall notice

Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.

View official notice →

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