Difference Between FDA Class I, II, And III Recalls

We oftentimes see news of a product recall, but are unaware that there are different types of recalls the U.S. Food and Drug Administration (FDA) can impose. The FDA’s main priority and responsibility is to make sure that drugs, cosmetic products, and some food items meet their safety guidelines. When a product violates regulations, it can create a potentially dangerous situations, at which point the FDA will step in and release a recall.

Class I Recall

A FDA Class I Recall is the most critical type of recall because it deals with a significant level and risk of danger, death, and serious injury. While this type of recall is rare, it’s important that consumers know what to do should a Class I Recall be set into motion. When the FDA releases this type of recall, they will put together a plan of action that specifically targets the manufacturer to see that the company follows through in compliance of the recall of the dangerous product.

Class II Recall

This type of recall is one that poses an intermediate threat level – while there is no immediate danger in regards to the product in question, there is still a high level of risk of death or serious injury. The plan of action taken with a Class II Recall is similar to that of a Class I Recall. The FDA will work with the manufacturer to spread the news of the recall and together they will take the product off store shelves in a timely and efficient manner.

Class III Recall

A Class III Recall is the lowest threat level recall the FDA can release. When there is no expected or perceived danger, the FDA will release this type of recall to pull products that are in violations of FDA regulations.

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