The Ten Worst Drug Recalls In The History Of The FDA

This year’s recall of certain types of Tylenol and Motrin by Johnson & Johnson (NYSE: JNJ), which began in January, brought back memories of the 1982 Tylenol recall. It affected as many as 21 million packages which were in circulation at the time. Johnson & Johnson’s reaction set the bar for other companies. It did not spare any expense to protect the public from what turned out to be a tiny number of tainted products.

Recalls are commonplace now. And, they are not just for drugs. Recent incidents include children’s beds and toys with high lead content. However, it is still the huge recalls of prescription drugs that garner the most headlines because they often harm the largest numbers of people. These recalls can also cost large pharmaceutical companies billions of dollars.

Many dangerous drugs have slipped past the FDA and found their way into the marketplace. When the agency approves a dangerous drug, there can be a number of consequences, often times tragic. Once news of a tragedy reaches the public, pressure mounts for FDA policy to change, as happened after the Thalidomide controversy in the 1960s.

Prior to 1962, there was no mechanism in the US to approve drugs before they went to market. Although the 1906 Food and Drugs Act required drugs to be accurately and honestly labeled, that was largely the extent of the oversight. In 1961, it was determined that Thalidomide caused horrifying birth defects. It is estimated that between 10,000 to 20,000 people were affected in what is considered to be among the worst medical disasters in history. Thalidomide prompted Congress to act, and the Kefauver-Harris Drug Amendments were passed in 1962, granting oversight of drugs to the FDA and compelling manufacturers to prove that their drugs are safe for public consumption.

Each of the drugs or group of drugs on this list drew a strong reaction from the public. In some cases, such as DES and PPA, what is shocking is how long the drugs were on the market before their devastating side effects were acknowledged. In others, the amount of money the drug company paid in settlements was so huge it drew public attention and ire. Still others were surprising because of the fraudulent manner in which they reached the market. This is a list of the worst drug recalls since the FDA became responsible for approving drugs in 1962.

Information for this article about litigation was obtained from the US Department of Justice and from LexisNexis. Facts about the history of each recall and statistics citing numbers of injuries or deaths were obtained from the archives of The New York Times, The Los Angeles Times, The Washington Post and USA Today.