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Class II · ModerateActive recall

Leader Earwax Removal Kit Earwax Removal Aid And Bulb

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

Does this affect you?
Check your lot numberLot: a) 1505333, expires: 2027-04; b) 1505144, 1505302, 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 byCardinal Health 110 DBA Leader
Brand nameLEADER EARWAX REMOVAL KIT EARWAX REMOVAL AID AND BULB
Generic nameCARBAMIDE PEROXIDE
Distributed by / forBell Pharmaceuticals, Inc
NDC70000-0689-1
Show the full FDA record
Full product labelLEADER, 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.
Recalling firmBell Pharmaceuticals, Inc
DistributionU.S Nationwide
Quantity5, 471 units
Recall initiated2026-06-25
Report date2026-07-22
Recall completed—
Recall numberD-0685-2026
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.