Reported Jul 22, 2026 · Ongoing · Updated Sep 16, 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);…
Bell Pharmaceuticals, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bell Pharmaceuticals, Inc · 200 W Beaver St · Belle Plaine, MN · 56011-1894
Is this the product you have?
LEADERCarbamide Peroxide 6.5%0.5 Fl Oz (15 mL)a) Kit -1 RUBBER BULB SYRINGE0.5 FL OZ DROPS(NDC 70000-0689-1)b) 1 bottle (NDC 70000-0688-1)DIST. BY CARDINAL HEALTHDUBLINOH 43017
- Lot codes and dates
- Lota) 1505333
- expires
2027-04b) 15051441505302
- expires2027-04
- Amount recalled
- 5, 471 units
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
- Nationwide
Why it was recalled
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
This product could cause temporary or reversible health problems — stop using it.
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