Bell Pharmaceuticals, Inc recalls LEADER
- Recalling company
- Bell Pharmaceuticals, Inc
- Product
- LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS, (NDC 70000-0689-1); b) 1 bottle (NDC 70000-0688-1), DIST. BY CARDINAL HEALTH, DUBLIN, OH 43017.
- 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
- 5, 471 units
- Lot / codes
- Lot: a) 1505333, expires: 2027-04; b) 1505144, 1505302, expires: 2027-04.
- Company location
- Belle Plaine, MN
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0685-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0685-2026 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.