Official recall notice
FDA DrugClass IINotable
FDA Recall: Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), NDC 70677-1154-01, Distributed by: McKe
- 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:1505161, 1505181, 1505301, 1505382, exp 2027-04.