The Recall Desk
ModerateFDA (Drugs)·D-0678-2026·Announced 2026-07-22

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
Hazard
  • subpotent-active-ingredient
  • 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 (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.

Related recalls

Same category