FDA Classifies Cough Drop Recall as Class II

The U.S. Food and Drug Administration has classified a voluntary recall of multiple cough drop products sold nationwide as a Class II action, following concerns about manufacturing quality at a facility in China. The recall, initiated by Xiamen Kang Zhongyuan Biotechnology Co., Ltd., on March 20, 2026, affects approximately 15 varieties distributed under several private-label brands, including Exchange Select, Caring Mill, MGC Health, QC Quality Choice, and Discount Drug Mart Food Market.

The action stems from observations noted during an FDA inspection of the manufacturer's facility on August 15, 2025, which raised questions about product quality, according to the agency's enforcement report. Specific details on the issues, such as potential contamination or labeling problems, have not been disclosed publicly. The Class II designation indicates that use of the products may cause temporary or medically reversible adverse health consequences, with the probability of serious effects considered remote.

Affected items include menthol cough suppressants and oral anesthetics in flavors such as honey lemon, cherry, black cherry, menthol, and vanilla honey, as well as sugar-free options...