CVS Earwax Removal Drops Recalled for Subpotent Active Ingredient
CVS-distributed earwax removal drops containing carbamide peroxide are being recalled because the active ingredient may degrade and become subpotent before the labeled expiration date, potentially leaving the product 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: This FDA Class II recall concerns active ingredient degradation and subpotency, not direct safety harm. With no reported illnesses or injuries and the primary issue being loss of product efficacy rather than risk of physical harm, this meets the Moderate (Score 2) criterion for manufacturing quality deviations.
Plain-English summary
Pharma Nobis LLC is recalling Fast Acting Earwax Removal System drops (carbamide peroxide 6.5%, 0.5 FL OZ per bottle) distributed by CVS Pharmacy due to manufacturing quality control deviations. The recalled product involves 69,615 bottles distributed nationwide in the USA.
The recall was initiated because the active ingredient may become subpotent before the labeled expiration date due to degradation. This means the product may not work as effectively as intended. The specific lot codes affected are: A70293, A70294, A70295 (Exp. 12/2023); A70746, A70747, A70748, A70749 (Exp. 01/2024); and A73051, A73052 (Exp. 05/2024). CVS Product #999532, UPC 0 50428 36475 8.
Consumers who have purchased this product should stop using it and may contact CVS Pharmacy or Pharma Nobis LLC for further instructions. No illnesses or injuries have been reported to date.
The recalled product
- Product
- Fast Acting Earwax Removal System (carbamide peroxide), 6.5%, 0.5 FL OZ (15 mL) Drops per bottle, OTC, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, CVS Product # 999532, UPC 0 50428 36475 8.
- Manufacturer
- Pharma Nobis LLC
- Category
- Drug — OTC Earwax Removal
- Hazard
- subpotency
- degradation
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 (12)
- Lots: A70293
- A70294
- A70295
- Exp. 12/2023
- A70746
- A70747
- A70748
- A70749
- Exp. 01/2024
- A73051
- A73052
- Exp. 05/2024
Distribution
Distributed nationwide across the United States.
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