Could cause temporary or reversible harm; serious harm is unlikely.
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
| Brand name | CAREONE EARWAX REMOVAL DROPS |
| Generic name | CARBAMIDE PEROXIDE |
| Active ingredient(s) | CARBAMIDE PEROXIDE |
| Distributed by / for | FOODHOLD U.S.A, LLC, LANDOVER, MD 20785 |
| NDC | 72476-838-34 |
| Full product label | CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34, DISTRIBUTED BY: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785. |
| Recalling firm | Bell Pharmaceuticals, Inc |
| Distribution | U.S Nationwide |
| Quantity | 1,201 units |
| Recall initiated | 2026-06-25 |
| Report date | 2026-07-22 |
| Recall completed | — |
| Recall number | D-0688-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Belle Plaine MN United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗