LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit… was recalled on June 25, 2026 in cooperation with the U.S. Food and Drug Administration because subPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%)..
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.
Lot: a) 1505333, expires: 2027-04; b) 1505144, 1505302, expires: 2027-04.
Units affected: 5, 471 units
Where it was sold: U.S Nationwide
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: Bell Pharmaceuticals, Inc
Not sure what you're entitled to? Read our guide: what to do if your product is recalled.
Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
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Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Potential foreign object contamination: rubber pieces
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