Food products, drugs, cosmetics, medical devices, and several other products all fall under the authority of the FDA (Food and Drug Administration). They monitor for defective or potentially harmful products and may suggest or request a recall. Recalls by the FDA are usually well publicized in the media. However, the more common occurrence is for the distributor or manufacturer to recall the product voluntarily. If the company does not issue a voluntary recall and ignores the requests of the FDA, the FDA will take the matter to court, seeking authorization for the government to seize the product.
Along with requiring companies to have established plans for dealing with recalls, there are strict guidelines, provided by the FDA, to which businesses must adhere when recalling defective or harmful products. These include the expectations of the FDA that companies take total responsibility for all aspects of the recall in order to ensure its success. Furthermore, the FDA requires notification and updates at all phases of the recall. The role of the FDA is to monitor recalls and make sure that the actions taken are sufficient. They also oversee the destruction of the product (or its reconditioning) and the investigations into the cause of the defect.
The FDA divides all recalls into three categories, based upon their degree of hazards.
- Class I Recall: These are the most serious recalls, for products that may cause death or serious injury. They include food that is found to be infected, defects in important medical devices, and mistakes on the labels of important or lifesaving drugs.
- Class II Recall: These are the products that may cause a minor injury or temporary health problem. Examples are non-lifesaving drugs that are found to be under strength.
- Class III Recall: The least serious of recalls, these are for products that will not cause any injury or death but still, in some way, violate FDA regulations. An incorrect pill count in a bottle is one such example.
Based upon these ratings and the specific details of each recall, the FDA determines the degree to which they will monitor the recalls. Information on the FDA and recalls can be found on their website, here.