Audiologist's Choice Carbamide Peroxide Earwax Removal Recalls
Bell Pharmaceuticals is recalling Audiologist's Choice Carbamide Peroxide earwax removal product due to subpotency: the active ingredient concentration is approximately 0.6% instead of the expected 6–7%, and the product has low pH.
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: This is an FDA Class II recall involving a subpotent drug with low pH. No illnesses, injuries, or hospitalizations are reported in the source text, and the hazard is primarily one of reduced efficacy rather than direct toxicity. Per the rubric, Class II recalls without reported adverse events typically score 2.
Plain-English summary
Bell Pharmaceuticals, Inc. is recalling Audiologist's Choice Earwax Removal System, a carbamide peroxide 6.5% topical/otic solution, due to subpotency. The recalled product contains significantly reduced active ingredient (approximately 0.6% carbamide peroxide versus the expected 6–7%) and exhibits low pH, which may affect product safety and efficacy.
The affected lots are Lot 1505123 (kit with washer bulb, NDC 59256-001-02) and Lot 1505131 (single bottle, NDC 59256-836-34), both expiring in April 2027. A total of 5,762 units were distributed nationwide by Oaktree Products Inc., St. Louis, MO.
Consumers who have purchased this product should stop using it. Anyone with questions or concerns should contact the manufacturer or consult a healthcare provider.
The recalled product
- Product
- AUDIOLOGISTS CHOICE EARWAX REMOVAL SYSTEM (CARBAMIDE PEROXIDE)
- Brand
- AUDIOLOGISTS CHOICE EARWAX REMOVAL SYSTEM
- Manufacturer
- Bell Pharmaceuticals, Inc
- Category
- Drug — Otic/Earwax Removal
- 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 (4)
- Lot: a)1505123
- expires: 2027-04
- b) 1505131
- expires: 2027-04.
UPCs (2)
- 0749566001020
- 0749566001013
Distribution
Distributed nationwide across the United States.
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