FDA recall D-0678-2026

Bell Pharmaceuticals, Inc · Class II · drug

Product

CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe & Drops- NDC 51316-823-00.), Distributed by: CVS Pharmacy., Inc. One CVS Drive, Woonsocket, RI 02895,

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-0678-2026