Quick Facts at a Glance
- Recall Date
- June 25, 2026
- Hazard Level
- HIGH
- Brands
- LEADER EARWAX REMOVAL KIT EARWAX REMOVAL AID AND BULB, Cardinal Health 110 DBA Leader
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- LEADER EARWAX REMOVAL KIT EARWAX REMOVAL AID AND BULB, Cardinal Health 110 DBA Leader
- Model numbers
- Lot: a) 1505333, expires: 2027-04, b) 1505144, 1505302, expires: 2027-04.
- UPC codes
- 70000-0689, 70000-0689-1, 70000-0688-1
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
June 25, 2026
Reported by FDA DRUG
July 22, 2026
RecallRadar source check
July 28, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Bell Pharmaceuticals, Inc or your healthcare provider for guidance. Notification method: Letter
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Full Description
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.. Generic: CARBAMIDE PEROXIDE; Brand: LEADER EARWAX REMOVAL KIT EARWAX REMOVAL AID AND BULB. Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).. Classification: Class II. Quantity: 5, 471 units. Distribution: U.S Nationwide
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
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