FDA-Drug2026-07-22Class IICHEMICAL

QC Quality Choice Carbamide Peroxide oral rinse recalled for subpotent active ingredient

LABEL MIX UPNationwide distributionDrugs

What this means

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.
The agency's original wording
Hazard

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

Intended for
Adults
Illnesses reported
None reported
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-0680-2026

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