Official recall notice

FDA DrugClass IINotable

FDA Recall: TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (ND

Recall date
2026-07-22
Category
Drug
FDA class
Class II

Why it was recalled

Hazard

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

Product description

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

Affected products

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

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