Official recall notice

FDA DrugClass IINotable

FDA Recall: FAMILY Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bulb Included, (NDC 55319-

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: 1505124, 1505311, 1505332, expires: 2027-04.

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