Drug Litigation Newsroom

FDA Drug Recall Policies

The recall of a defective or possibly harmful consumer product often is highly publicized in newspapers and on news broadcasts.  This is especially true when a recall involves foods, drugs, cosmetics, medical devices, and other products regulated by FDA.  Despite this publicity, FDA's role in recall activities is often misunderstood not only by consumers, but also by the news media, and occasionally even by the regulated industry.  The following headlines, which appeared in two major daily newspapers, are good examples of that misunderstanding: "FDA Orders Peanut Butter Recall," and "FDA Orders 6,500 Cases of Red-Dyed Mints Recalled."

The headlines are wrong in indicating that the Agency can "order" these recalls.  The Federal Food, Drug, and Cosmetic Act, (the law) does not generally authorize FDA to "order" a manufacturer to recall a food, cosmetic or supplement.  The agency may request a product recall if the firm is not willing to remove dangerous products from the market without FDA's written request.  Only when a medical device, human tissue products, and infant formula pose a risk to human health; that the law specifically authorizes FDA to prescribe a recall and to rule on the scope and extent of the same

The guidelines categorize all recalls into one of three classes according to the level of hazard involved.

• Class I recalls are for dangerous or defective products that predictably could cause serious health problems or death. Examples of products that could fall into this category are a food found to contain botulinal toxin, food with undeclared allergens, a label mix-up on a life saving drug, or a defective artificial heart valve.
• Class II recalls are for products that might cause a temporary health problem, or pose only a slight threat of a serious nature.  One example is a drug that is under-strength but that is not used to treat life-threatening situations.
• Class III recalls are for products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing regulations.  Examples might be a container defect (plastic material delaminating or a lid that does not seal); off-taste, color, or leaks in a bottled drink, and lack of English labeling in a retail food.