FDA-Drug2026-07-22Class IICHEMICAL
Clinere Carbamide Peroxide recalled for subpotent formulation
LABEL MIX UPNationwide distribution
Clinere Carbamide Peroxide recalled for reduced strength
Bell Pharmaceuticals is recalling Clinere Carbamide Peroxide ear cleaning solution due to manufacturing defects that reduced the active ingredient strength to approximately 0.6% instead of the expected 6–7%. The affected bottles also have a lower-than-normal pH. These defects may reduce the product's effectiveness.
- Check if you have Clinere Carbamide Peroxide with lot numbers 1504241, 1504291, or 1504301 (all expire 2027-03).
- Stop using affected bottles.
- Contact Bell Pharmaceuticals or your pharmacy 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
29, 474 units
Manufactured in
200 W Beaver St, Belle Plaine, MN, United States
Products
Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL); b) 1 bottle of Clinere Carbamide Peroxide (0,50 fl. oz. (15 mL), Dist. by: Quest Products LLC, Pleasant Prairie, WI 53158, NDC 68229-102-01.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0679-2026More Bell Pharmaceuticals, Inc recalls
- 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-Drug2026-07-22Leader 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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