Leader Carbamide Peroxide Earwax Removal Kit Recalled for Subpotency
Bell Pharmaceuticals is recalling Leader Carbamide Peroxide 6.5% Earwax Removal Kit due to subpotency—the active ingredient is significantly reduced (approximately 0.6% versus the expected 6–7%) and the pH is low.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with a manufacturing/formulation defect (subpotency and low pH). No illnesses or injuries are reported in the source, and the hazard is a loss of efficacy rather than a direct health risk, making this a moderate severity recall.
Plain-English summary
Bell Pharmaceuticals, Inc. is recalling the Leader Carbamide Peroxide 6.5% Earwax Removal Kit (0.5 Fl Oz / 15 mL) distributed nationwide. The product contains affected lot numbers 1505333 and 1505144/1505302 (all expiring April 2027) and consists of a rubber bulb syringe and carbamide peroxide solution (NDC 70000-0689-1 and NDC 70000-0688-1).
The product is subpotent—the assay of the active ingredient is significantly lower than expected (approximately 0.6% versus the expected 6–7%) and the solution has a low pH. This deficiency may reduce the product's effectiveness at the intended strength.
Consumers with this product should stop using it and contact their pharmacist or healthcare provider for guidance. The product is distributed by Cardinal Health, Dublin, OH.
The recalled product
- Product
- LEADER EARWAX REMOVAL KIT EARWAX REMOVAL AID AND BULB (CARBAMIDE PEROXIDE)
- Brand
- LEADER EARWAX REMOVAL KIT EARWAX REMOVAL AID AND BULB
- Manufacturer
- Bell Pharmaceuticals, Inc
- Category
- Drug — OTC Earwax Removal
- Hazard
- subpotency
- low-pH
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot: a) 1505333
- expires: 2027-04
- b) 1505144
- 1505302
- expires: 2027-04.
UPCs (2)
- 0096295143799
- 0096295143782
Distribution
Distributed nationwide across the United States.
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