According to the Daily Mail, Xiamen Kang Zhongyuan Biotechnology Co., Ltd. initiated the recall last month after a 2025 FDA investigation documented observations that may affect product quality. The recall involves 15 menthol-containing cough drop products sold in various bag sizes with expiration dates extending into 2026. The affected products were distributed in 25-, 30-, 80- and 90-count bags with expiration dates ranging from May to October 2026.
The FDA designated this as a Class II recall, which the agency defines as a situation where product use may cause temporary or medically reversible adverse health consequences, or where serious health risks are remote. No illnesses or adverse effects have been reported from the recalled cough drops to date.
Specific details about the quality issues that prompted the recall were not disclosed in the FDA's enforcement report. The FDA has not yet sent a warning letter to Xiamen Kang Zhongyuan Biotechnology regarding its facility inspection, nor has the agency issued specific guidance to consumers who may have purchased the recalled products. This leaves several questions unanswered, including what specific quality defects led to the recall and what actions consumers should take if they have purchased the affected cough drops.