Bell Pharmaceuticals, Inc recalls CAREone
- Recalling company
- Bell Pharmaceuticals, Inc
- Product
- 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
- SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jun 25, 2026
- Reported
- Jul 22, 2026
- Distribution
- U.S Nationwide
- Status
- Ongoing
- Quantity
- 1,201 units
- Lot / codes
- Lot:1505141, exp 2027-04.
- Company location
- Belle Plaine, MN
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0688-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0688-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.