FDA-Drug2026-07-22Class IICHEMICAL
Bell Pharmaceuticals FAMILY Wellness Carbamide Peroxide recalled for subpotent drug—significantly reduced active ingredient
LABEL MIX UPNationwide distribution
FAMILY Wellness Carbamide Peroxide recalled for subpotent formulation
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.
Hazard
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
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-0683-2026More Bell Pharmaceuticals, Inc recalls
- FDA-Drug2026-07-22Clinere Carbamide Peroxide recalled for subpotent formulation
- 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
- FDA-Drug2026-07-22CAREone Carbamide Peroxide 6.5% oral rinse recalled for subpotent active ingredient
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