CAREONE Earwax Removal Drops Recall Announced
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
FDA announces Class II recall of CAREONE Carbamide Peroxide earwax removal drops 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 CAREONE earwax removal drops after testing found the product was subpotent, with low pH and reduced assay levels of approximately 0.6% versus the expected 6.5%.
Which Products Are Affected
CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34. Lot: 1505141, expiration 2027-04. A total of 1,201 units were distributed nationwide.
What You Should Do
Consumers should verify the lot number on purchased bottles against the recalled lot.
Why This Matters
This is an ongoing Class II recall affecting over 1,200 units of an over-the-counter earwax removal product sold across the United States.
Source
FDA recall number D-0688-2026, reported July 22, 2026.
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 (768 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.