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Market Withdrawal vs. a Recall

It is very easy to mix up the terms market withdrawal and recall if you are not familiar with the nuances of each action. The general public might mistake a recall for a market withdrawal because people typically associate recalls with “removing” items from the market. While it may seem a bit confusing, these are actually two different processes with separate definitions and unique steps. 

A Brief Recap of Recalls

To summarize, a recall is a company’s removal or correction of a marketed product that violates certain laws. A recall can be voluntary in which the firm initiates it or mandatory if a regulatory agency, like the FDA, forces the recall. The regulatory agency and the affected company will work together to remove or correct the product while informing the public. 

Manufacturers and agencies attempt to track consumer reports related to drugs, food and beverages, medical devices, and various manufactured goods. They do so to mitigate risks to public health and safety. A recall will occur if consumer reports or trials reveal that an item may threaten the public’s welfare. The FDA will assign a category for recalled products that fall under its jurisdiction. A recall may be considered a Class I, Class II, or Class III depending on the likelihood and hazards the product in question presents. Class I is the most serious type of recall because it involves products that can cause severe injury or death in users. 

How a Market Withdrawal Differs From a Recall

A market withdrawal occurs when a firm removes or corrects a product, but only over a minor violation. While recalls are open to legal action by the FDA, market withdrawals are not. The primary difference between market withdrawals and recalls depends on the gravity of the violation. Some recalled drugs or devices have the ability to injure or even kill consumers, but a market withdrawal involves more trivial or minute matters. 

According to the FDA, common market withdrawals include a company rotating its stock or repairing or replacing equipment used to manufacture the product. Even a drop in sales for the drug or device can push a company to implement a market withdrawal. Meanwhile, a recall tends to be a more urgent matter since these products can directly harm consumers and patients. Market withdrawals are also relevant when a company improves upon the device or drug and creates a more effective version. The company will adopt a market withdrawal for the outdated product instead of a recall. 

For example, in February 2022, Abbott Laboratories recalled its powdered infant formula due to the presence of dangerous bacteria. Families allege that their babies grew ill or even died after consuming the contaminated formula. A market withdrawal would not have been appropriate in this situation. Instead, Abbott issued a recall rather than a market withdrawal because its products presented an immediate risk of sickness or death for infants. 

A recall is suitable in cases where the device or drug endangers the public. However, companies reserve market withdrawals for inconsequential changes and products that pose no hazards to consumers.

How Our Law Firm Can Help You

The Lake Law Firm was founded by Edward J. Lake, Esq., a personal injury lawyer for over 25 years. Our dedicated team of attorneys is committed to seeking justice on behalf of those who have suffered injury or death due to the negligence of others. Our experienced attorneys handle many different types of pharmaceutical drugs, medical devices, and other defective products. The lawyers in our firm have helped collect millions of dollars for their clients. The Lake Law Firm will advocate for you and your rights. Please contact us for a free confidential case evaluation at (888) 274-0139.