FDA-Drug2026-07-22Class IICHEMICAL
Leader Carbamide Peroxide 6.5% recalled for subpotent drug — significantly reduced active ingredient
LABEL MIX UPNationwide distribution
Leader Carbamide Peroxide recalled for reduced potency
Some bottles and kits of Leader Carbamide Peroxide 6.5% contain significantly less active ingredient than labeled (about 0.6% instead of 6–7%) and have an abnormally low pH. The product may not work as intended for ear wax removal or oral rinse.
- Check your carbamide peroxide product for lot numbers 1505333, 1505144, or 1505302 (all expire April 2027).
- If you have an affected lot, stop using it and contact your pharmacist or doctor for a replacement.
- Do not use the product if you are unsure of the lot number.
Hazard
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Sold states
U.S Nationwide
Affected count
5, 471 units
Manufactured in
200 W Beaver St, Belle Plaine, MN, United States
Products
LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS, (NDC 70000-0689-1); b) 1 bottle (NDC 70000-0688-1), DIST. BY CARDINAL HEALTH, DUBLIN, OH 43017.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0685-2026More 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-Drug2026-07-22Meijer 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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