The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0681-2026·Announced 2026-07-22

TopCare Earwax Removal Kit Recalled for Subpotent Drug Content

Bell Pharmaceuticals is recalling TopCare Earwax Removal Kit (Carbamide Peroxide 6.5%) because the drug is subpotent with significantly reduced active ingredient (~0.6% vs. expected 6–7%) and low pH. The affected product was distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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: The FDA classification is Class II. The hazard is subpotency (reduced active ingredient and low pH) without any reported illnesses or injuries, and the source text does not indicate a high-risk pathogen or serious adverse-event reports. This fits the Moderate category for a labeling/quality defect with no documented harm.

Plain-English summary

Bell Pharmaceuticals, Inc. is recalling TopCare Health Earwax Removal Kit containing Carbamide Peroxide 6.5% (0.5 FL OZ / 15 mL) distributed by TOPCO ASSOCIATES LLC. The recall affects approximately 16,156 units distributed nationwide in the U.S.

The product is subpotent, containing significantly reduced active ingredient content (approximately 0.6% versus the expected 6–7%) and exhibits low pH. The affected lots are: 1505122 and 1505343 (kit with washer bulb and drops, NDC 36800-835-33, expires April 2027), and lots 1505142 and 1505341 (single bottle, NDC 36800-835-34, expires April 2027).

Consumers who have purchased this product should stop using it and consult their healthcare provider if they have questions or experience any adverse effects. The product may be returned to the point of purchase for a refund or replacement.

The recalled product

Product
TOPCARE EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE)
Brand
TOPCARE EARWAX REMOVAL KIT
Manufacturer
Bell Pharmaceuticals, Inc
Category
Drug — OTC Topical / Otic
Hazard
Affected units
16,156

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 (6)

  • Lot: a) 1505122
  • 1505343
  • expires: 2027-04
  • b) 1505142
  • 1505341
  • expires: 2027-04.

UPCs (1)

  • 0036800776913

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 →

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