FDAHealthJune 25, 2026
Bell Pharmaceuticals, Inc — 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 HE
⚠️ SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 25, 2026
U.S Nationwide
What's affected?
- 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.
- UPC
- 0096295143799
- Lot code
- a)
Additional details
Lot: a) 1505333, expires: 2027-04; b) 1505144, 1505302, expires: 2027-04.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 5, 471 units.
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