FDA-Drug2026-07-22Class IICHEMICAL
CVS Health Carbamide Peroxide 6.5% recalled for subpotent formulation
What this means
CVS Health Carbamide Peroxide 6.5% oral rinse contains significantly less active ingredient than labeled (about 0.6% instead of 6–7%) and has an abnormally low pH. The product may not work as intended for oral care.
- Check your CVS Health Carbamide Peroxide 6.5% bottle or kit for NDC 51316-822-00 or 51316-823-00.
- Do not use the product if you have one of the affected lots.
- Return it to your CVS Pharmacy or contact CVS customer service 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
All ages
Illnesses reported
None reported
Sold states
U.S Nationwide
Affected count
106,301 units
Manufactured in
200 W Beaver St, Belle Plaine, MN, United States
Products
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,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0678-2026More Bell Pharmaceuticals recalls
- FDA-Drug2026-07-22Audiologist's Choice Carbamide Peroxide recalled for subpotent active ingredient
- FDA-Drug2026-07-22Foster & Thrive Carbamide Peroxide recalled for significantly reduced active ingredient
- FDA-Drug2026-07-22Good Neighbor Pharmacy Carbamide Peroxide 6.5% recalled for subpotent solution
- FDA-Drug2026-07-22TopCare Health Carbamide Peroxide 6.5% recalled for subpotent formula
- FDA-Drug2026-07-22CAREone Carbamide Peroxide 6.5% oral rinse recalled for subpotent active ingredient
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