Quality Choice Earwax Removal Kit Carbamide Peroxide Subpotent Drug Recall
Bell Pharmaceuticals is recalling Quality Choice Earwax Removal Kit (Carbamide Peroxide 6.5%) due to subpotent drug content, with assay levels significantly reduced (approximately 0.6% versus expected 6–7%) and low pH levels.
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 with no reported illnesses or injuries. The hazard is subpotency (reduced active ingredient) and pH deviation, which create a risk of therapeutic failure rather than direct harm; the source text does not report any adverse health consequences, making this a moderate severity precautionary recall.
Plain-English summary
Bell Pharmaceuticals, Inc. is recalling Quality Choice Earwax Removal Kit (Carbamide Peroxide 6.5%, 0.5 FL. OZ.) distributed nationwide in the United States. The product is being recalled because it is subpotent, meaning the active ingredient concentration is significantly reduced compared to the labeled strength, with assay levels measuring approximately 0.6% instead of the expected 6–7%. Additionally, the product has a low pH level.
Affected lot numbers are: 1505121 and 1505342 (expiration date April 2027) for the washer bulb package (NDC 63868-026-15), and lot 1505381 (expiration date April 2027) for the single-bottle package (NDC 63868-027-16). A total of 15,843 units were distributed.
Consumers who have purchased this product should discontinue use and consult a healthcare provider if they have questions about their treatment. The product may not be effective due to the reduced active ingredient level. Consumers may return the product to the place of purchase or contact Bell Pharmaceuticals or C.D.M.A., Inc. (the distributor) for further instructions.
The recalled product
- Product
- QUALITY CHOICE EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE)
- Brand
- QUALITY CHOICE EARWAX REMOVAL KIT
- Manufacturer
- Bell Pharmaceuticals, Inc
- Category
- Drug — Over-the-Counter Topical
- 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 (5)
- Lot: a) 1505121
- 1505342
- exp 2027-04
- b) 1505381
- exp 2027-04.
UPCs (1)
- 0635515987623
Distribution
Distributed nationwide across the United States.
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