Audiologist's Choice Earwax Removal System Recall
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 5,762 units of Audiologist's Choice earwax removal products due to subpotent carbamide peroxide.
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 Audiologist's Choice earwax removal products after testing showed the drug is subpotent, with low pH and reduced assay levels of approximately 0.6% versus the expected 6.7%.
Which Products Are Affected
The recall covers 5,762 units distributed nationwide in the United States. Affected products include:
- AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) Kit - Washer Bulb Included (NDC 59256-001-02), Lot 1505123, expires 2027-04
- AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) 1 bottle (NDC 59256-836-34), Lot 1505131, expires 2027-04
Products were manufactured by Oaktree Products Inc. and distributed by Bell Pharmaceuticals, Inc. in Belle Plaine, MN. Recall number D-0682-2026. Classification: Class II.
What You Should Do
Consumers should stop using the affected products and contact the recalling firm for return or refund instructions. The firm initiated notification by letter.
Why This Matters
The subpotent formulation may reduce the product's effectiveness for earwax removal.
Source
FDA recall D-0682-2026 (ongoing, report date 20260722).
Original source: FDA Official Notice ↗
Related FDA Recalls
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.
Similar body length
Nearest notices by article body length (1,179 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 9, 2026.
Frequently Asked Questions
Common questions about this FDA recall.