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Food and Drug Administration drug recall classifications

On Behalf of | Sep 12, 2019 | Pharmaceutical Litigation

As anyone in Ohio with high blood pressure has discovered in recent months, many of the prescription medications out there could cause substantial harm to those who take them. While the Food and Drug Administration can force a recall, the companies who make the medications issue most of the recalls voluntarily. What the FDA does is provide information to the public.

Part of that information involves how the agency classifies the recalls it orders and/or monitors them. Each recall receives a classification based on the potential harm it could do to the public. A Class I recall means that there is a serious risk of injury or death due to the defective or dangerous product that is the subject of the recall. A product under a Class II recall may only pose a slightly serious risk or result in a temporary health issue that should resolve with time and treatment. A product recall classified as Class III may not pose any harm to anyone, but it does violate federal manufacturing or labeling laws.

When it comes to prescription medications, most people would assume that any recall would fall under Class I, but not all do. Even so, anytime a drug could cause harm to someone, it should be taken seriously. The problem is that not all recalls reach the affected parties in time.

The Food and Drug Administration attempts to get the information to the appropriate parties in a timely manner, but by the time a recall occurs, it may be too late. Ohio residents who suffer harm due to a recalled medication may have legal recourse. In order to know for sure, it may be useful to consult with an attorney experienced in pharmaceutical litigation.


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