LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL… recall
FDA recall D-0685-2026 · initiated Jun 25, 2026
Bell Pharmaceuticals, Inc recalled LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRING… in Jun 2026 — an FDA Class II recall (D-0685-2026) because SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 5, 471 units
Details
- 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.
- Recalling company
- Bell Pharma
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S Nationwide
- Initiated
- Jun 25, 2026
- FDA report date
- Jul 22, 2026
Frequently asked
- Was LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRING… recalled?
- Bell Pharmaceuticals, Inc recalled LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRING… in Jun 2026 — an FDA Class II recall (D-0685-2026) because SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). May cause temporary or medically reversible harm; low probability of serious harm.
- Why was LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRING… recalled?
- Per the FDA enforcement record, the reason for recall D-0685-2026 was: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Is a recalled LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRING… dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRING… are affected?
- Distributed: U.S Nationwide. The recall covers these lots — Lot: a) 1505333, expires: 2027-04; b) 1505144, 1505302, expires: 2027-04.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0685-2026.