Family Wellness Earwax Removal Kit Recall

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Bell Pharmaceuticals, Inc. is recalling 11,977 units of Family Wellness Carbamide Peroxide 6.5% earwax removal kits due to subpotent drug levels.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on August 9, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.

What Happened

Bell Pharmaceuticals, Inc. initiated a voluntary recall of Family Wellness earwax removal kits after testing showed the product is subpotent, with low pH and significantly reduced assay (~0.6% vs expected ~6.7%).

Which Products Are Affected

The recall covers FAMILY Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bulb Included (NDC 55319-835-01), distributed by Midwood Brands LLC. Affected lots are 1505124, 1505311, and 1505332 (expires 2027-04). A total of 11,977 units were distributed nationwide in the United States.

What You Should Do

The recall is voluntary and firm-initiated via letter. Consumers should check lot numbers on purchased products.

Why This Matters

This Class II recall involves a subpotent over-the-counter drug product distributed across the United States.

Source

FDA recall number D-0683-2026. Data from FDA enforcement report.

Original source: FDA Official Notice ↗

All FDA Recalls →

Nationwide notices with similar length or severity timing 8

Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Bell Pharmaceuticals, Inc. is recalling 11,977 units of Family Wellness Carbamide Peroxide 6.5% earwax removal kits due to subpotent drug levels.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.