FDA Elevates Nationwide Cough-Drop Recall to Class II

Overview

• The FDA, which set the Class II risk level Friday, April 10, says the cough-drop recall is still active with no end date.
• Xiamen Kang Zhongyuan Biotechnology began the voluntary recall on March 20 after inspectors in China reported observations on August 15, 2025 that could affect product quality.
• The action covers 15 over-the-counter items across five brands sold nationwide, and consumers are urged to match lot numbers and expiration dates and stop using any that appear on the list.
• No illnesses linked to the drops have been reported, and for Class II drug recalls the FDA notes people can generally keep taking a medicine unless the company says otherwise.
• Specific inspection findings have not been disclosed, and the FDA says updates on oversight and any fixes at the plant will follow as the recall progresses.