What is the Difference Between a Product Recall and a Market Withdrawal?

product liability | November 26, 2021

Anytime it is discovered that a product can cause harm to consumers, it should be removed from the market immediately. When it comes to removing a product from the market, this typically happens in one of two ways – a product recall or a market withdrawal. Here, we want to specifically define product recalls and market withdrawals so that you have an understanding of the difference between the two and how they can affect you and your loved ones.

What is the Difference Between a Product Recall and a Market Withdrawal?

Understanding Product Recalls

Information provided by the Food and Drug Administration (FDA) says that a “recall is a method of removing or correcting products that are in violation of laws administered by the Food and Drug Administration (FDA).”

Drug manufacturers have a legal obligation to provide products that are safe for consumers to use. Anytime drugs or medical devices are shown to be defective or dangerous for consumers, companies have a responsibility to protect the public from them.

Drug companies can choose to voluntarily recall a defective drug, but the FDA could also request that the company recall the product. In general, FDA orders mandating a recall are rare. Usually, the court of public opinion prevails, and companies recall a drug before these mandates become a reality.

When recall does occur, the FDA monitors the recall process and issues guidance to ensure that the company has a plan to let consumers who have taken the drug know that there is an issue. These notifications can involve press releases, emails to consumers, direct mailing campaigns, and notices to doctors who prescribed the drug.

Understanding Market Withdrawals

Market withdrawals typically do not involve dangerous or defective drugs or any type of FDA law or regulation violation. Any drug that faces a market withdrawal will likely have had a minor defect or issue that is not serious enough for the FDA to find any type of legal violation or ask for a recall.

Some of the most common examples of market withdrawals include companies rotating their stock or repairing or replacing equipment used to produce the drug in question. For example, if there are allegations of tampering with a specific drug, but the allegation did not originate with the manufacturing process, a company might choose to withdraw the drug from the market just to be safe. Typically, after a company corrects a known issue, they will return the drug to the market.

Additionally, if a drug manufacturer determines that sales of a drug have been declining over time, they may choose to discontinue the drug and withdrawal the remaining product from the market.

Working With an Attorney

If you or somebody you love has been injured or become ill as a result of a defective prescription medication or medical device, you need to speak to a product liability attorney immediately. A skilled lawyer can use their resources to conduct a complete investigation into the incident and help you recover any compensation you are entitled to. This can include coverage of your medical bills related to the defective product, lost income if you cannot work while you recover, household out-of-pocket expenses, loss of enjoyment of life damages, and more.