CAREone Earwax Removal Drops Recalled for Subpotent Active Ingredient
CAREone Earwax Removal Drops (Carbamide Peroxide 6.5%) are recalled because the product contains significantly reduced active ingredient (~0.6% vs. expected ~6–7%) and low pH, making it ineffective.
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 no reported illnesses or injuries. The hazard is subpotency and low pH affecting an OTC topical otic product; the source text does not report hospitalization or adverse health events, making this a precautionary/quality defect recall.
Plain-English summary
Bell Pharmaceuticals, Inc. is recalling CAREone Earwax Removal Drops (Carbamide Peroxide 6.5%, 0.5 FL OZ/15 mL) distributed nationwide. The product is subpotent, with measured assay of approximately 0.6% carbamide peroxide compared to the expected 6–7%, and exhibits low pH.
Lot 1505141 with expiration date April 2027 (NDC 72476-838-34) is affected. A total of 1,201 units were distributed in the United States.
Consumers who have purchased this product should stop using it and consult a healthcare provider or pharmacist for alternative earwax removal solutions. The product's subpotency means it will not perform its intended function. Consumers may return the product to the place of purchase for a refund or replacement.
The recalled product
- Product
- CAREONE EARWAX REMOVAL DROPS (CARBAMIDE PEROXIDE)
- Brand
- CAREONE EARWAX REMOVAL DROPS
- Manufacturer
- Bell Pharmaceuticals, Inc
- Category
- Drug — OTC Otic / Earwax Removal
- Hazard
- subpotent
- 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 (2)
- Lot:1505141
- exp 2027-04.
UPCs (1)
- 0041520154446
Distribution
Distributed nationwide across the United States.
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