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.
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: 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
- subpotent-drug
- 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 (6)
- Lot: a) 1505122
- 1505343
- expires: 2027-04
- b) 1505142
- 1505341
- expires: 2027-04.
UPCs (1)
- 0036800776913
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- ModerateAudiologist's Choice Carbamide Peroxide Earwax Removal Recalls
FDA (Drugs) · 2026-07-22
- ModerateFamily Wellness Carbamide Peroxide Earwax Removal Kit Subpotent Drug
FDA (Drugs) · 2026-07-22
- ModerateCAREone Earwax Removal Drops Recalled for Subpotent Active Ingredient
FDA (Drugs) · 2026-07-22
- ModerateClinere Ear Wax Remover Recalled for Subpotent Carbamide Peroxide
FDA (Drugs) · 2026-07-22
- ModerateFoster & Thrive Carbamide Peroxide 6.5% Recalled for Subpotent Strength
FDA (Drugs) · 2026-07-22