The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0679-2026·Announced 2026-07-22

Clinere Ear Wax Remover Recalled for Subpotent Carbamide Peroxide

Bell Pharmaceuticals is recalling Clinere Ear Wax Remover nationwide because the product contains significantly reduced active ingredient and low pH. The affected lots were distributed throughout the United States.

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: The source is classified as FDA Class II. No illnesses or injuries are reported in the source text. The defect is subpotency (reduced active ingredient) rather than contamination or a high-risk hazard, making this a moderate-severity manufacturing defect without documented adverse health consequences.

Plain-English summary

Bell Pharmaceuticals, Inc. is recalling Clinere Ear Wax Remover containing carbamide peroxide (6.5%) due to a manufacturing defect. The product contains significantly reduced active ingredient (~0.6% versus the expected ~6–7%) and has a low pH.

The recalled product includes two package configurations: 2 bottles of 0.5 fl. oz. (15 mL) each, and 1 bottle of 0.5 fl. oz. (15 mL). The affected lots are 1504241, 1504291, and 1504301, all with expiration dates in March 2027. The product is distributed by Quest Products LLC of Pleasant Prairie, Wisconsin.

Approximately 29,474 units have been distributed nationwide across the United States. Consumers who have purchased this product should stop use and consult a healthcare provider if they have questions about their care.

The FDA classified this as a Class II recall. Further information is available on the FDA's drug safety and availability page.

The recalled product

Product
CLINERE EAR WAX REMOVER (CARBAMIDE PEROXIDE)
Brand
CLINERE EAR WAX REMOVER
Manufacturer
Bell Pharmaceuticals, Inc
Category
Drug — OTC Otic
Hazard

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) 1504241
  • exp 2027-03
  • b) 1504291
  • 1504301
  • exp 2027-03.

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

Same manufacturer · Bell Pharmaceuticals, Inc

See all →

Same hazard · subpotency

See all →

Similar recalls