FDA-Drug2026-07-22Class IICHEMICAL

Clinere Carbamide Peroxide recalled for subpotent formulation

LABEL MIX UPNationwide distributionDrugs

What this means

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.
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
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-0679-2026

More Bell Pharmaceuticals recalls

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