Drug recall D-0685-2026
Product
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.
Reason for recall
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Lots and codes
Lot: a) 1505333, expires: 2027-04; b) 1505144, 1505302, expires: 2027-04.
Recall details
- Recalling firm
- Bell Pharmaceuticals, Inc, Belle Plaine, MN
- Quantity
- 5, 471 units
- Distribution
- U.S Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 25, 2026
Related products
- Leader Earwax Removal Kit Earwax Removal Aid and Bulb – drug information
- NDC 70000-0688 Leader Earwax Removal Drops Earwax Removal Aid · Carbamide Peroxide 65 mg/mL · Cardinal Health, Inc.
- NDC 70000-0689 Leader Earwax Removal Kit Earwax Removal Aid and Bulb · · Cardinal Health 110 DBA Leader