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CLASS II · ModerateFDA

Bell Pharmaceuticals, Inc recalls TopCare Health

📅 Jun 25, 2026 · 📍 Nationwide
Recalling company
Bell Pharmaceuticals, Inc
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.
Reason
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Jun 25, 2026
Reported
Jul 22, 2026
Distribution
U.S Nationwide
Status
Ongoing
Quantity
16,156 units
Lot / codes
Lot: a) 1505122, 1505343, expires: 2027-04; b) 1505142, 1505341, expires: 2027-04.
Company location
Belle Plaine, MN
Recall type
Voluntary: Firm initiated
Recall number
D-0681-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0681-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.