FDA-Drug2026-07-22Class IICHEMICAL
CAREone Carbamide Peroxide 6.5% oral rinse recalled for subpotent active ingredient
LABEL MIX UPNationwide distribution
CAREone Carbamide Peroxide recalled for reduced potency
CAREone Carbamide Peroxide 6.5% oral rinse (lot 1505141, expiring April 2027) contains significantly less active ingredient than labeled (~0.6% instead of ~6.5%) and has a lower pH than specified. The product may not work as intended for its intended use.
- Check if you have lot 1505141 (printed on the bottle).
- Do not use the product if you have this lot.
- Contact your pharmacist or healthcare provider if you have questions about your oral rinse.
Hazard
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Sold states
U.S Nationwide
Affected count
1,201 units
Manufactured in
200 W Beaver St, Belle Plaine, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0688-2026More 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-Drug2026-07-22QC Quality Choice Carbamide Peroxide oral rinse recalled for subpotent 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
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