Warning
Bell Pharmaceuticals Recalls CAREone
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0688-2026Drug / Pharmaceutical
Bell Pharmaceuticals Recalls CAREone
Bell Pharmaceuticals, Inc · Class II — Moderate Risk
Product Description
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.
Reason for Recall
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
U.S Nationwide
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
A Class II FDA recall has been issued for a pharmaceutical product from Bell Pharmaceuticals, Inc, initiated on June 25, 2026. SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). This recall covers 1,201 units, distributed in U.S Nationwide. While not the highest severity, consumers should exercise caution and stop using the product until the recall is resolved.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects.