Class II
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.
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Recall number
- D-0681-2026
- Report date
- July 22, 2026
- Classification
- Class II
- Status in dataset
- Ongoing
- Recalling firm
- Bell Pharmaceuticals, Inc
- Generic names
- CARBAMIDE PEROXIDE
- Brand names
- TOPCARE EARWAX REMOVAL KIT
- Product NDCs
- 36800-835
Code and lot information
Lot: a) 1505122, 1505343, expires: 2027-04; b) 1505142, 1505341, expires: 2027-04.
Distribution
U.S Nationwide
Do not stop or change a prescribed medication based only on this page.Contact your pharmacist or prescriber and compare the exact product, manufacturer, NDC, and lot information.
Source and limitations
This page reflects a public openFDA Drug Enforcement record. The dataset was last checked on July 28, 2026. openFDA states that enforcement data should not be used alone to issue public alerts or track the full lifecycle of a recall.
Review the official FDA Drug Recalls page and the underlying openFDA query.