FDAFDA · Food and drugs·Recall number D-0685-2026
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.
Published July 22, 2026 · Recall initiated: June 25, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- LEADER EARWAX REMOVAL KIT EARWAX REMOVAL AID AND BULB
- Manufacturer
- Bell Pharmaceuticals, Inc
- Distributor
- U.S Nationwide
- UPC
- 0096295143799
- Lot
- Lot: a) 1505333, expires: 2027-04; b) 1505144, 1505302, expires: 2027-04.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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