CareOne Carbamide Peroxide Recalled Due to Subpotent Drug

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for CareOne, carbamide peroxide 6.5%, 0.5 fl oz (15 mL). The affected batch has been identified as Lot 1505141 (expires April 2027), affecting 1201 units.
• The recall was initiated by Bell Pharmaceuticals, Inc due to a subpotent drug, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
• CareOne carbamide peroxide is used to treat earwax buildups.

The FDA has issued a Class II recall for CareOne, carbamide peroxide 6.5%, 0.5 fl oz (15 mL), affecting 1201 units. This product is being recalled by Bell Pharmaceuticals, Inc based in Belle Plaine, Minnesota. The recall was initiated on June 25, 2026, and received a Class II classification on July 14, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.

The recall was initiated due to a subpotent drug; the product has a low pH and a significantly reduced assay (0.6% vs expected 6.7%). This deficiency affects Lot 1505141, which will expire in October 2027. Bell Pharmaceuticals sent out a public notice via letter; no press release has been issued for this recall.

CareOne carbamide peroxide is an over-the-counter product used to treat earwax buildups by softening earwax and making it easier to remove. Pharmacists should identify and quarantine Lot 1505141, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. July 22, 2026. Accessed July 22, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=221308