FDA-Drug2026-07-22Class IICHEMICAL

Foster & Thrive Carbamide Peroxide recalled for significantly reduced active ingredient

LABEL MIX UPNationwide distributionDrugs

What this means

Foster & Thrive Carbamide Peroxide 6.5% oral rinse was found to contain significantly less active ingredient than labeled (~0.6% instead of ~6-7%), along with abnormally low pH. The affected product may not work as intended for its intended use. No injuries have been reported.

  • Check your product for lot numbers 1505161, 1505181, 1505301, or 1505382 with expiration date 04/2027.
  • If you have this product, contact your pharmacist or healthcare provider for guidance on a replacement.
  • Do not use the recalled product.
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
31,094 units
Manufactured in
200 W Beaver St, Belle Plaine, MN, United States
Products
Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), NDC 70677-1154-01, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0686-2026

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