FDA Drugs recall ·
TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER… recall
- Recall number
- D-0681-2026
- Date
- (initiated June 25, 2026)
- Company / brand
- Bell Pharmaceuticals, Inc
200 W Beaver St, Belle Plaine, MN, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 16,156 units
- Hazard tags
- Potency
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: a) 1505122, 1505343, expires: 2027-04; b) 1505142, 1505341, expires: 2027-04.
Distribution
U.S Nationwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0681-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.