FDAFDA · Food and drugs·Recall number D-0681-2026
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.
Published July 22, 2026 · Recall initiated: June 25, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- TOPCARE EARWAX REMOVAL KIT
- Manufacturer
- Bell Pharmaceuticals, Inc
- Distributor
- U.S Nationwide
- UPC
- 0036800776913
- Lot
- Lot: a) 1505122, 1505343, expires: 2027-04; b) 1505142, 1505341, expires: 2027-04.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.