Understanding FDA Recall Classes and Why They Matter to You

The United States Food and Drug Administration (FDA) is responsible for a number of things, but most notably, they oversee the food and medications that Americans have access to. There are also some products that are neither food-based nor medical that fall under the jurisdiction of this government entity.

One of the most important roles that the FDA handles is recalling items, whether they’re food, medication, or other products, that pose a threat to public health and safety.

When this happens, the FDA issues a recall designed to get the product out of the public’s hands so they can determine what went wrong in production and how to prevent it from ever happening again.

Every year, the FDA takes more than 1,000 items off the market. The process begins when they receive credible evidence that a product poses a threat to public safety.

Once the FDA gets word about a bad product, they are responsible for alerting the public about the impending recall. Then, the recall gets categorized as a Class 1, 2, or 3. During this phase, the FDA further categorizes the recall as either mandatory or voluntary.

In general, most recalls, which focus on the manufacturer more than the consumer, are voluntary. However, in an extreme instance, they can require the product pulled from the market.

After the threat level has been put into the appropriate class, the FDA tells consumers how they should proceed, which can include any level of direction ranging from throwing the product away to deep cleaning any surfaces or utensils that the product came in contact with.

The process comes to an end after the FDA evaluates the manufacturer and then makes sure that the recall is complete and that the threat to public health and safety has been eliminated.

One of the most important parts of FDA recalls revolves around the FDA recall classes. Today, learn more about what each of the three levels of an FDA recall means and how it can impact you.

What are the FDA Recall Classes?

As we briefly discussed a moment ago, the FDA puts its recalls into one of three categories. These categories decrease in severity.

Understanding how these recall classes work and what you need to do when you find out a product that you’ve used or have in your home is part of those recalls can help you protect yourself and your loved ones.

FDA Recall Class III

Considered “low risk,” the FDA recall Class III recall is the least severe type of recall that the FDA issues. If you find out about a product that you’ve been using that gets mentioned in a Class III recall, you probably don’t have much to worry about.

In most cases, these recalls focus on packaging issues, which, while they are technically in violation of FDA guidelines, don’t pose a massive threat to your health and safety. For instance, regular soda getting put into a can that’s marked as diet soda during packaging may fall under a Class III recall.

Class III recalls also apply to products that don’t have adequate warnings on them. While this may seem like a more serious problem than a Class III recall would indicate, the Food and Drug Administration generally considers this to be a mild risk.

In some instances, quality issues may lead to a Class III recall, too. If you have a taillight in your car that burns out significantly quicker than it should according to existing industry standards, the FDA can recall that light.

For the most part, these issues are not going to create any sort of risk to your health or safety, so these recalls are more about making the consumer aware of potential issues with quality or labeling.

FDA Recall Class II

When it comes to FDA recall classes, a Class II is a bit more dangerous than a Class III, but it’s still not considered likely to create serious health problems or death.

Instead, using a product that’s part of a Class II recall may lead to moderate health issues that are considered reversible. For some people, depending on their preexisting health conditions, a Class II recall can be incredibly dangerous, so it’s important to be aware of what you’re dealing with.

Some of the most common Class II recalls involve food products that have a potential allergen in them, but that ingredient is not on the label.

For instance, if a company used peanuts or peanut oil in a product but failed to put that on the label, whether by mistake or because of negligence, people who have severe nut allergies would be in danger if they consumed the product.

Issues with manufacturing, especially in the pharmaceutical industry, also lead to some Class II recalls.

For instance, if a drug doesn’t meet the quality standards that have been set forth by the FDA and other regulatory agencies, but is not dangerous when taken as directed, it may be subject to a Class II recall.

This can include something as minor as the capsule that a medication is in breaking down too quickly when it gets to the stomach. These recalls aren’t usually dangerous but they do not meet the quality standards that are expected of pharmaceutical companies.

Class II recalls are incredibly important to pay attention to, especially if you or someone in your home has health issues that may be made worse by consuming or using a product that’s part of the recall. Most of all, these recalls allow consumers to make an informed decision about whether they want to continue to use a product.

FDA Recall Class I

FDA Class I recalls are reserved for the most severe quality issues, as using or consuming products that are part of a Class I recall can lead to serious health issues or even death.

Contaminated food, mislabeled medications, and other potentially life-threatening products are part of these recalls. Fortunately, these are the rarest recalls that the FDA issues.

If a pharmaceutical manufacturer puts a drug on the market that’s mislabeled, meaning it contains a drug other than the drug in the bottle, that company would be subject to a Class I recall. This applies to prescription medicines and over-the-counter (OTC) meds.

For instance, if you have an allergy to acetaminophen, the active ingredient in Tylenol, you may choose to purchase Motrin instead since its active ingredient is ibuprofen. If a pharmaceutical company accidentally sent out ibuprofen bottles that had acetaminophen in them, this would be a severe health risk.

Generally, when it comes to food, Class I recalls from the FDA are reserved for food that’s contaminated.

If food is found to have something like salmonella or E. coli in it, the FDA would issue a Class I recall to alert the public to get rid of the product and to open an investigation into the company that produced it to figure out how the food became contaminated with potentially deadly bacteria.

What Should I Do if Something I Have is Recalled?

The FDA issues more than 1,000 recalls every year, so it’s unlikely that you’ll know about everyone that comes out.

Fortunately, the media generally picks up on the more severe Class I recalls which increases the amount of information that’s available. You can also visit the FDA’s website and search for products that you have in your home to make sure that they haven’t been recalled.

The website also contains information about which class of recall products you have fall under.

If you find that something in your home is part of a recall, look at what level of recall applies to it and make an informed decision. If you believe that you or someone in your home is facing a health risk because of this issue, seek medical attention as quickly as possible.