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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 69,615
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.
Related recalls
Same manufacturer · Pharma Nobis LLC
See all →- ModerateMagnesium Citrate Laxative Recalled for Bacterial Contamination
FDA (Drugs) · 2024-05-22
- ModerateOTC Magnesium Citrate laxative recalled for microbial contamination
FDA (Drugs) · 2024-05-22
- HighMagnesium Citrate Oral Solution Recalled for Bacterial Contamination
FDA (Drugs) · 2024-01-24
- HighMagnesium Citrate Laxative Oral Solution Recalled for Bacterial Contamination
FDA (Drugs) · 2024-01-24
- HighWalgreens Dye-Free Magnesium Citrate Saline Laxative Recalled for Bacterial Contamination
FDA (Drugs) · 2024-01-24
Same hazard · subpotency
See all →- SeverePfizer Recalls Subpotent Levoxyl Levothyroxine Sodium Tablets
FDA (Drugs) · 2026-10-28
- ModerateLeader Carbamide Peroxide Earwax Removal Kit Recalled for Subpotency
FDA (Drugs) · 2026-07-22
- ModerateGood Neighbor Pharmacy Earwax Removal Drug Recalled for Low Potency
FDA (Drugs) · 2026-07-22
- ModerateClinere Ear Wax Remover Recalled for Subpotent Carbamide Peroxide
FDA (Drugs) · 2026-07-22
- ModerateFoster & Thrive Carbamide Peroxide 6.5% Recalled for Subpotent Strength
FDA (Drugs) · 2026-07-22
Similar recalls
- ModerateCVS Health Earwax Removal Drops Recalled for Subpotent Active Ingredient
FDA (Drugs) · 2026-07-22
- ModerateCAREone Earwax Removal Drops Recalled for Subpotent Active Ingredient
FDA (Drugs) · 2026-07-22
- ModerateGood Neighbor Pharmacy Earwax Removal Drug Recalled for Low Potency
FDA (Drugs) · 2026-07-22
- 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
- ModerateQuality Choice Earwax Removal Kit Carbamide Peroxide Subpotent Drug Recall
FDA (Drugs) · 2026-07-22