FDA recall D-0688-2026

Product

CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34, DISTRIBUTED BY: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785.

Reason for recall

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

Distribution

U.S Nationwide

Key facts

Status

Ongoing

Initiation date

2026-06-25

Report date

2026-07-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Belle Plaine, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0688-2026