CVS Health Earwax Removal Drops Recalled for Subpotent Active Ingredient
CVS Health Earwax Removal Drops are being recalled because the product contains significantly reduced active ingredient (approximately 0.6% instead of the expected 6–7%) and has low pH. The recalled product may not work as intended.
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 where the active ingredient is significantly reduced and pH is low. No hospitalization or illness reports are mentioned in the source. The hazard is that the product will not work as intended rather than cause direct harm; therefore, the recall is classified as Moderate.
Plain-English summary
CVS Health Earwax Removal Drops Earwax Removal Aid, a topical over-the-counter drug containing carbamide peroxide 6.5%, is being recalled by Bell Pharmaceuticals, Inc. The product is available in two formats: individual bottles (NDC 51316-822-00) and kits with a bulb and syringe (NDC 51316-823-00), distributed by CVS Pharmacy, Inc.
The recall was initiated because the recalled lots contain significantly reduced levels of the active ingredient carbamide peroxide (approximately 0.6% versus the expected 6–7%) and exhibit low pH. This subpotency means the product may not effectively remove earwax as labeled.
The recall affects 106,301 units distributed nationwide. The affected lot numbers are: 1505121, 1504242 (expiration 2027-03); 1505132, 1505182, 1505191, 1505291, 1505331 (expiration 2027-04); 1504231, 1504311 (expiration 2027-03); and 1505312, 1505321 (expiration 2027-04).
Consumers who have purchased the recalled product should stop using it and may return it to CVS Pharmacy for a refund or replacement. For additional information, consumers can contact Bell Pharmaceuticals, Inc. or visit the FDA website.
The recalled product
- Product
- CVS HEALTH EARWAX REMOVAL DROPS EARWAX REMOVAL AID (CARBAMIDE PEROXIDE)
- Brand
- CVS HEALTH EARWAX REMOVAL DROPS EARWAX REMOVAL AID
- Manufacturer
- Bell Pharmaceuticals, Inc
- Category
- Drug — Over-the-Counter Topical
- Affected units
- 106,301
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 (14)
- Lot: a) 1505121
- 1504242
- exp 2027-03
- 1505132
- 1505182
- 1505191
- 1505291
- 1505331
- exp 2027-04
- b) 1504231
- 1504311
- 1505312
- 1505321
- exp 2027-04.
UPCs (1)
- 0050428078273
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Bell Pharmaceuticals, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 11 products in this recall →Related recalls
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