Class II
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.
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Recall number
- D-0685-2026
- Report date
- July 22, 2026
- Classification
- Class II
- Status in dataset
- Ongoing
- Recalling firm
- Bell Pharmaceuticals, Inc
- Generic names
- CARBAMIDE PEROXIDE
- Brand names
- LEADER EARWAX REMOVAL KIT EARWAX REMOVAL AID AND BULB
- Product NDCs
- 70000-0689
Code and lot information
Lot: a) 1505333, expires: 2027-04; b) 1505144, 1505302, expires: 2027-04.
Distribution
U.S Nationwide
Do not stop or change a prescribed medication based only on this page.Contact your pharmacist or prescriber and compare the exact product, manufacturer, NDC, and lot information.
Source and limitations
This page reflects a public openFDA Drug Enforcement record. The dataset was last checked on September 23, 2026. openFDA states that enforcement data should not be used alone to issue public alerts or track the full lifecycle of a recall.
Review the official FDA Drug Recalls page and the underlying openFDA query.