FDA-Drug2026-07-22Class IICHEMICAL

Bell Pharmaceuticals FAMILY Wellness Carbamide Peroxide recalled for subpotent drug—significantly reduced active ingredient

LABEL MIX UPNationwide distributionDrugs

What this means

Bell Pharmaceuticals' FAMILY Wellness Carbamide Peroxide 6.5% oral rinse has been found to contain significantly less active ingredient than labeled (~0.6% instead of ~6–7%), and has a lower pH than specified. The affected lots will not work as intended for oral care.

  • Check your product against lot numbers 1505124, 1505311, or 1505332 (expiring April 2027).
  • Stop using the product if you have one of these lots.
  • 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
11, 977 units
Manufactured in
200 W Beaver St, Belle Plaine, MN, United States
Products
FAMILY Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bulb Included, (NDC 55319-835-01), DISTRIBUTED BY: MIDWOOD BRANDS LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0683-2026

More Bell Pharmaceuticals recalls

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