How Does A Product or Drug Get Recalled by the FDA?

We have often heard about products being pulled from the shelf due to defects in the packaging or some other sort of health risk. This blog will give a little more detail about what a recall is and how the public is informed.

A recall is when a product is removed from the market or a correction is made to the product because it is either defective or potentially harmful. Recalls may be conducted on a company’s own initiative, by FDA request, or by FDA order under statutory authority.

Classes of Product and Drug Recalls

There are three different classes of product and drug recalls. They are as follows:

  • Class I recall: A situation in which there is a reasonable probability that the use of exposure to a violative product will cause serious adverse health consequences or death. An example of this type of recall would be a food that contained botunlinum toxin, a food with undeclared allergens, or a label mix-up on a life-saving drug.
  • Class II recall: A situation in which the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. An example of this type of recall would be a drug that is under-strength but is not used to treat a life-threatening situation.
  • Class III recall: A situation in which the use of or exposure to a violative product is not likely to cause adverse health consequences but still violates FDA labeling or manufacturing regulations. An example of this type of recall would be a container defect such as a lid that does not seal or a lack of English labeling in a retail food.

How Does the Public Find Out About an FDA Recall?

The FDA works with industry and state partners to publish press releases and other public notices about product and drug recalls that may present a significant risk to the consumer or user of the product. Not all recalls that have press releases are published to the FDA website. Not all recalls are announced to the media, but they are listed in the FDA’s weekly Enforcement Report.

The FDA seeks publicity about a product and drug recall only when it believes the public needs to be alerted to a serious hazard. When a recalled product has been widely distributed, the news media is often used as it can reach large numbers of people. The FDA website offers e-mail alerts. It also has accounts on Facebook and Twitter. Attorney ads are also commonly used to announce recalls to the public.

April 11, 2013 | Categories: Class Action |