Official recall notice
FDA DrugClass IINotable
FDA Recall: LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS,
- 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) 1505333, expires: 2027-04; b) 1505144, 1505302, expires: 2027-04.