The Recall Desk
ModerateFDA (Drugs)·D-0685-2026·Announced 2026-07-22

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

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.

Part of a larger recall action

This product is one of 11 recalled by Bell Pharmaceuticals, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →

Related recalls

Same manufacturer · Bell Pharmaceuticals, Inc

See all →

Same hazard · subpotency

See all →