The Recall Desk
ModerateFDA (Drugs)·D-0683-2026·Announced 2026-07-22

Family Wellness Carbamide Peroxide Earwax Removal Kit Subpotent Drug

Family Wellness Carbamide Peroxide 6.5% earwax removal kits are being recalled because they are subpotent with low pH and significantly reduced active ingredient content (approximately 0.6% versus the expected 6–7%). Consumers should stop using affected lots and consult their pharmacist.

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 for a subpotent OTC drug with no reported illnesses or injuries. The source text indicates a deficiency in active ingredient content and pH, but the hazard is primarily related to reduced efficacy rather than direct toxicity or contamination. Class II recalls are typically scored as 2–3; the absence of hospitalization reports or high-risk pathogen involvement supports a Moderate (2) classification.

Plain-English summary

Bell Pharmaceuticals, Inc is recalling Family Wellness Earwax Removal kits containing Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) with washer bulb. The product is a Human OTC Drug distributed nationwide in the United States.

The recall affects approximately 11,977 units. The affected lots are 1505124, 1505311, and 1505332, which expire in April 2027. The product was distributed by Midwood Brands LLC (500 Volvo Parkway, Chesapeake, VA 23320).

The product has been found to be subpotent, with a low pH and significantly reduced assay of approximately 0.6% compared to the expected 6–7% of the active ingredient carbamide peroxide. This means the product does not contain the labeled amount of active ingredient needed for its intended earwax removal purpose.

Consumers with affected lots should stop using the product and consult a pharmacist if they have questions.

The FDA classification for this recall is Class II.

The recalled product

Product
FAMILY WELLNESS EARWAX REMOVAL EARWAX AND BULB (CARBAMIDE PEROXIDE)
Brand
FAMILY WELLNESS EARWAX REMOVAL EARWAX AND BULB
Manufacturer
Bell Pharmaceuticals, Inc
Category
Drug — OTC Earwax Removal
Hazard
  • subpotent-drug
  • low-pH
  • reduced-assay

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 (4)

  • Lot: 1505124
  • 1505311
  • 1505332
  • expires: 2027-04.

UPCs (1)

  • 0032251921483

Distribution

Distributed nationwide across the United States.

Related recalls

Same category