FDA-Drug2026-07-22Class IICHEMICAL
QC Quality Choice Carbamide Peroxide oral rinse recalled for subpotent active ingredient
LABEL MIX UPNationwide distribution
QC Quality Choice Carbamide Peroxide recalled for reduced potency
QC Quality Choice Carbamide Peroxide 6.5% oral rinse has significantly lower active ingredient levels than labeled (about 0.6% instead of 6–7%) and an unusually low pH. This means the product may not work as intended for oral care. The recall affects specific lots distributed nationwide.
- Check if you have QC Quality Choice Carbamide Peroxide with lot number 1505121, 1505342, or 1505381 (expiration April 2027).
- Stop using the product if you have an affected lot.
- Contact Bell Pharmaceuticals or your retailer for a refund or replacement.
Hazard
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Sold states
U.S Nationwide
Affected count
15, 843 units
Manufactured in
200 W Beaver St, Belle Plaine, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0680-2026More Bell Pharmaceuticals, Inc recalls
- FDA-Drug2026-07-22Clinere Carbamide Peroxide recalled for subpotent formulation
- FDA-Drug2026-07-22Bell Pharmaceuticals FAMILY Wellness Carbamide Peroxide recalled for subpotent drug—significantly reduced active ingredient
- FDA-Drug2026-07-22Leader Carbamide Peroxide 6.5% recalled for subpotent drug — significantly reduced active ingredient
- FDA-Drug2026-07-22Meijer Carbamide Peroxide 6.5% oral rinse recalled for subpotent drug — significantly reduced active ingredient
- FDA-Drug2026-07-22CAREone Carbamide Peroxide 6.5% oral rinse recalled for subpotent active ingredient
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