Product containers with dollar bills on pastel green surface

Whether you are a manufacturer or a consumer, no one likes the news of a product being pulled from the market.

But it is very important to know why the product is facing such consequence.

Is it a product recall or a market withdrawal?

How can you know what is the difference between the two? Does it really matter?

The truth?


Knowing the difference between the two may help a company or a manufacturer save valuable money and time.

On the other hand, a knowledge of the difference between product recall and market withdrawal will help consumers get away from serious adverse health consequences and extra hospital bills.

This article will benefit both manufacturers and consumers by helping them understand the difference between the two, as this piece contains all that you need to know about the key differences between a product recall and a market withdrawal.

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

According to the U.S. Food and Drug Administration, a product recall is an action taken by a drug manufacturer or firm to remove a drug or medical product from the market because it violates the law that the FDA administers.

Aside from when products happen to be violating a federal law, companies also engage in recalling products when the drug or device has been found to contain defects or if it poses dangers to consumers.

The process of recalling a product involves the removal of drugs or medical products from sale, distribution, or consumption because they are potentially harmful or can cause adverse effects. Reasons behind the recall of a product from the market can be packaging errors, product defect, or contamination.

Take, for example, the recall of the popular heartburn medication, Zantac, which was recalled by the FDA after it was found to be contaminated with concerning levels of a potential cancer-causing agent known as N-nitrosodimethylamine (NDMA).

But even though the contaminated batches have already been removed from the market by several American health agencies, Zantac lawsuits are being filed as we speak, because people who took the medication over the course of several years developed cancer after taking the heartburn medication are now seeking compensation and fighting for their rights.

Product recalls can either be at trade or consumer levels.

The difference between recalls and market withdrawals mainly lies in the potential risk or danger that the drug or device could cause consumers who might use them.

What Does it Mean if a Product gets Recalled?

A product recall can also be defined as a request to return, exchange, or replace a product after a manufacturer or consumer group finds defects or problems on a food or drug that could cause serious harm to consumers and patients, or cause legal issues for the manufacturers.

Recalls may be conducted on a firm’s own initiative, by FDA request, or by FDA order under statutory authority.

A product recall is more often a voluntary action that companies take in order to protect the health and safety of the public.

When a recall happens, the FDA issues a guidance to the manufacturer to ensure that the company has a concrete plan to notify consumers who may have used or taken the drug upon its recall.

These recall notifications can come in the form of press releases, direct mail and email to consumers, and direct notices to doctors who may have prescribed the drug to their patients.

Additionally, during a product recall, companies also offer refunds for the return of the drug impacted by the recall to certain medical offices or retail outlets.

Depending on the problem with the drug under recall, the company may replace it, or your doctor may prescribe you a different drug. The FDA also posts recall announcements on its website.

What are the Types of Drug Recalls?

Recalls are classified by the Food and Drug Administration according to the seriousness of a product’s potential harms (Class I, Class II, Class III). Here’s how the FDA defines each category of product recall:

  • Class I recall – A situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
  • 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 the probability of serious adverse health consequences is remote.
  • Class III recall – A situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Serious Adverse Health Consequences

Through these standards, the FDA will assign the classification of a recall, whether it fits the Class I, Class I, or Class III category.

This is done by the FDA to indicate the level of health hazard the product being considered for recall poses to the public.

Do You get Money Back for Recalled Items?

The short answer?


Consumers who have purchased any food or drug that has now been deemed unsafe is due a refund or replacement.

If you look at the FDA’s website and the announcements that they make on product recalls, a number of manufacturers give a full refund or product replacement for the item affected by the recall.

Scientists in a laboratory holding vials

First, you need to verify that your product is indeed a part of the recall, and then determine who will be giving out the refund, and what they need from you.

In general, notices of recalls come from manufacturers who sell the product.

But as different recalls come with different rules, these guidelines mainly depend on whether it is a retailer or a manufacturer who is going to give you back your money.

Your refund may come in a straightforward refund, where you return the product where you purchased it. You can also return the item to any store in the company’s chain, bringing your receipt in for a refund is also an option, and the best option of them all: you can call the distributing company or mail them to get a refund or replacement for the product impacted by the recall.

What is a Market Withdrawal?

A market withdrawal happens when a firm’s distributed an item and that certain product has a minor violation that would not be subject to FDA legal action.

In short, withdrawals of products occur when a manufacturer removes the product from the supply chain because of reasons not involving health and safety reasons. For instance, market withdrawals can be because of repairs, normal stock rotation practices, or routine equipment adjustments.

When any of these happen, withdrawals take place. The firm removes the item from the market or corrects the violation or the minor issue which is not technically a threat to the safety of consumers.

Market withdrawals usually occur because of quality issues.

What is an example of a Minor Violation that would not be Subject to FDA Legal Actions?

An example of a minor violation is when a product is mislabeled with the wrong weight, manufacturers may want to withdraw it from the supply chain. On the other hand, if the product displays the wrong ingredients and dosage, then it will have to be recalled.

Manufacturers also go for market withdrawal as a precaution, waiting for an investigation by the FDA or the company itself of a potential public health risk.

Once there’s a public health risk established from the use of a product, then that certain food or drug has to be recalled.

A market withdrawal can also occur in a different scenario. If a drug company notices that a drug has been having a decline in sales over time, it may decide to discontinue sales of the drug and withdraw the remaining batches of the drug from the market.

Additionally, manufacturers can also choose to withdraw a drug from the market if they have replaced the drug with a more effective and newer drug.

Do You have a Defective Product Claim?

This is where the importance of knowing the difference between a product recall and a market withdrawal can prove to be very helpful.

Anyone could be a potential victim of a defective or potentially harmful drug or device.

Whether the drug company engaged in a product recall or market withdrawal, it could have an effect on certain legal actions that you might take for the rightful compensation you can have.

That’s right.

It means that these companies or drug manufacturers can be subject to legal action, especially if you have suffered injuries and adverse health consequences from using a defective drug or medical device, and if they manufactured these products while being fully aware of its potential risks to the public.

If you or loved one want to pursue legal action, the Drugwatcher team is here to help you. Get in touch with us now and we will provide you with the necessary legal steps you could take to fight for your rights and make abusive drug companies accountable.

Who knows?

Maybe the time to fight for the compensation that you justly deserve might be today.

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