Once a product is in the market for the public to use, any unpredictable problems can lead to a recall. However, recalls are always voluntary. Sometimes a company discovers a problem and recalls a product on its own without consulting FDA. Other times the company recalls a product after the FDA raises concerns regarding their product. For any medical and drug product, there is a classification before exporting in the market. Similarly, there is a classification for recalls as well. the Guideline for Class I state any dangerous or defective products that possibly could cause serious health problems or death. Class II defines products that might cause a temporary health problem or a slight threat of a serious nature. Class III defines products that are unlikely to cause any health reaction but violating FDA labeling or manufacturing laws. Therefore, when the labeling is mismatched or incorrectly posted, I think they are required to be recalled by the FDA. And regulated in a proper manner before sending for use in the market.