The recall affects cough drops sold in 25-, 30-, 80- and 90-count bags with expiration dates ranging from May to October 2026. According to the Daily Mail, the FDA has classified this as a Class II recall, indicating that use of the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The same source reports that no illnesses or other adverse effects have been reported to date.
Multiple questions remain unanswered for consumers. The Daily Mail notes that specific conditions or details of the quality issues were not disclosed in the FDA's enforcement report, and it is unclear exactly how many lots were recalled. A product quality issue in a recall generally means a product fails to meet mandated safety, manufacturing or labeling standards, which could pose health risks, but the specific risks are unknown. According to the Daily Mail, the FDA has not yet sent a warning letter to Xiamen Kang Zhongyuan Biotechnology Co., Ltd. related to its facility inspection, and the agency has also not issued specific guidance to consumers who may have purchased the products.