FDAHealthJune 25, 2026
Bell Pharmaceuticals, Inc — TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800-835-34), DISTRIBUTED BY TOPCO AS
⚠️ 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
- TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800-835-34), DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007.
- UPC
- 0036800776913
- Lot code
- a)
Additional details
Lot: a) 1505122, 1505343, expires: 2027-04; b) 1505142, 1505341, expires: 2027-04.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 16,156 units.
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