TopCare Earwax Removal Kit Recall Issued
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 16,156 units of TopCare Health Carbamide Peroxide 6.5% earwax removal products 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 TopCare Health earwax removal products after testing found the drug was subpotent, with low pH and significantly reduced assay (~0.6% vs expected ~6.7%).
Which Products Are Affected
The recall covers TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL):
- a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33)
- b) 1 bottle (NDC 36800-835-34) Distributed by Topco Associates LLC, Elk Grove Village, IL 60007. Affected lots are a) 1505122, 1505343 (exp 2027-04); b) 1505142, 1505341 (exp 2027-04). A total of 16,156 units distributed nationwide in the United States.
What You Should Do
This is a firm-initiated voluntary recall classified as Class II. Consumers should refer to the recalling firm or FDA for additional guidance on affected 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-0681-2026, 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 (1,036 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.