Clinere Ear Wax Remover Recalled for Subpotent Carbamide Peroxide
Bell Pharmaceuticals is recalling Clinere Ear Wax Remover nationwide because the product contains significantly reduced active ingredient and low pH. The affected lots were distributed throughout the United States.
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 source is classified as FDA Class II. No illnesses or injuries are reported in the source text. The defect is subpotency (reduced active ingredient) rather than contamination or a high-risk hazard, making this a moderate-severity manufacturing defect without documented adverse health consequences.
Plain-English summary
Bell Pharmaceuticals, Inc. is recalling Clinere Ear Wax Remover containing carbamide peroxide (6.5%) due to a manufacturing defect. The product contains significantly reduced active ingredient (~0.6% versus the expected ~6–7%) and has a low pH.
The recalled product includes two package configurations: 2 bottles of 0.5 fl. oz. (15 mL) each, and 1 bottle of 0.5 fl. oz. (15 mL). The affected lots are 1504241, 1504291, and 1504301, all with expiration dates in March 2027. The product is distributed by Quest Products LLC of Pleasant Prairie, Wisconsin.
Approximately 29,474 units have been distributed nationwide across the United States. Consumers who have purchased this product should stop use and consult a healthcare provider if they have questions about their care.
The FDA classified this as a Class II recall. Further information is available on the FDA's drug safety and availability page.
The recalled product
- Product
- CLINERE EAR WAX REMOVER (CARBAMIDE PEROXIDE)
- Brand
- CLINERE EAR WAX REMOVER
- Manufacturer
- Bell Pharmaceuticals, Inc
- Category
- Drug — OTC Otic
- 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) 1504241
- exp 2027-03
- b) 1504291
- 1504301
- exp 2027-03.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- ModerateTopCare Earwax Removal Kit Recalled for Subpotent Drug Content
FDA (Drugs) · 2026-07-22
- 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
- ModerateFoster & Thrive Carbamide Peroxide 6.5% Recalled for Subpotent Strength
FDA (Drugs) · 2026-07-22