FDAFDA recall D-0685-2026 · Jul 22, 2026
Bell Pharmaceuticals, Inc: LEADER recall
Recall found
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 for recall
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot: a) 1505333, expires: 2027-04; b) 1505144, 1505302, expires: 2027-04.
- Quantity
- 5, 471 units
- Distribution
- U.S Nationwide
- Recalling firm
- Bell Pharmaceuticals, Inc, Belle Plaine, MN
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-25
Source: openFDA enforcement record D-0685-2026 · search recall number D-0685-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.