FDA recall D-0680-2026

Product

QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included (NDC 63868-026-15); b) 1 bottle (NDC 63868-027-16), Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376.

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-0680-2026