FDA Drug recall D-0685-2026
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)
- FDA Drug
- Class II
- ongoing
- Published 2026-07-22
On 2026-07-22 the FDA classified a Class II recall of 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) by Bell Pharmaceuticals, citing subPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0685-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-25 |
| Published | 2026-07-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Bell Pharmaceuticals |
| Distribution | US |
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%).
Identifiers
| ndc | 70000-0689-1 |
|---|---|
| ndc | 70000-0688-1 |
| code_info | Lot: a) 1505333, expires: 2027-04; b) 1505144, 1505302, expires: 2027-04. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0685-2026%22
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