FDA-Drug2026-07-22Class IICHEMICAL
TopCare Health Carbamide Peroxide 6.5% recalled for subpotent formula
LABEL MIX UPNationwide distribution
TopCare Health Carbamide Peroxide recalled for reduced potency
TopCare Health Carbamide Peroxide 6.5% oral rinse has significantly lower active ingredient than labeled (about 0.6% instead of 6–7%) and abnormal pH. The product may not work as intended for whitening or cleaning teeth.
- Check your TopCare Health Carbamide Peroxide 6.5% bottle for lot numbers 1505122, 1505343, 1505142, or 1505341 (all expire April 2027).
- Stop using the product if you have one of the affected lots.
- Contact your pharmacist or healthcare provider if you have questions about treatment.
Hazard
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Sold states
U.S Nationwide
Affected count
16,156 units
Manufactured in
200 W Beaver St, Belle Plaine, MN, United States
Products
TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800-835-34), DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0681-2026More 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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