Official recall notice
FDA DrugClass IINotable
FDA Recall: CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BU
- 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) 1505121, 1504242, exp 2027-03; 1505132, 1505182, 1505191, 1505291, 1505331, exp 2027-04; b) 1504231, 1504311, exp 2027-03; 1505312, 1505321, exp 2027-04.