Topcare Earwax Removal Kit Liquid
FDA Recall NDC 36800-835
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Topcare Earwax Removal Kit (NDC 36800-835). A significant event, classified as Class II, was initiated on Jun 25, 2026 by Topco Associates Llc. The reported reason for this action was: "SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%)."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Jun 25, 2026
Jul 22, 2026
16,156 units
Recall Profile & Regulatory Data
Event ID
99278
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Bell Pharmaceuticals, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S Nationwide
Product Description
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.
Batch or Lot Expiration Information
Lot# Lot: a) 1505122, 1505343, expires: 2027-04; b) 1505142, 1505341, expires: 2027-04.
Affected Packages Involved in this Recall
36800-835-33Product
36800-835-34Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
