FlaggedRx← Medication recall checkHome
Class II · ModerateActive recall

Topcare Earwax Removal Kit

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot: a) 1505122, 1505343, expires: 2027-04; b) 1505142, 1505341, expires: 2027-04.
Where it was soldU.S Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byTOPCO ASSOCIATES LLC
Brand nameTOPCARE EARWAX REMOVAL KIT
Generic nameCARBAMIDE PEROXIDE
Active ingredient(s)CARBAMIDE PEROXIDE
Distributed by / forTOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007
NDC36800-835-33
Show the full FDA record
Full product labelTopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800-835-34), DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007.
Recalling firmBell Pharmaceuticals, Inc
DistributionU.S Nationwide
Quantity16,156 units
Recall initiated2026-06-25
Report date2026-07-22
Recall completed—
Recall numberD-0681-2026
ClassificationClass II
FDA statusOngoing
Origin on fileBelle Plaine MN United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.