← FDA ENFORCEMENT
D-0685-2026Class II

Bell Pharmaceuticals, Inc

Recalling firm
Bell Pharmaceuticals, Inc
Product type
Drug
Status
Ongoing
Report date
2026-07-22
Distribution
U.S Nationwide
Firm state
MN
Product quantity
5, 471 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Product description

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.

Code / lot info

Lot: a) 1505333, expires: 2027-04; b) 1505144, 1505302, expires: 2027-04.

Other recalls SPEQ maps to Validation & Qualification
2026-07-22Class IIBell Pharmaceuticals, Inc2026-07-22Class IIBell Pharmaceuticals, Inc2026-07-22Class IIBell Pharmaceuticals, Inc2026-07-22Class IIBell Pharmaceuticals, Inc
See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.