The U.S. Food & Drug Administration (FDA) categorizes drug recalls into three different classes after evaluating the risk and extent of the harm to consumers that the recalled drug poses. The FDA determines what the classes of drug recalls are, evaluates the risk of each recalled drug, and classifies the drug according to the appropriate level. Class I recalls are drugs that are so dangerous or defective that they could result in serious health problems or death and Class II recalls pose a slight or temporary risk to health. Finally, Class III recalled drugs pose no real risk of adverse health reactions, but which are problematic because they contain incorrect labeling or instructions.
Defining Drug Recalls
Drug manufacturers perform drug recalls when they voluntarily take harmful or defective drugs off the market and out of the hands of consumers. These drugs typically violate some law or FDA regulation. Some of the most common reasons for drug recalls include:
- Safety concerns, such as adverse health consequences
- Inconsistencies in strength or potency
Some of these problems are much more serious than others, which leads to the class system that the FDA uses to categorize recalled drugs. After a recall, the manufacturer can fix the defect in the drug, which is easy in the case of a minor mislabeling problem.
How Drug Recalls Work
Drug recalls can go into effect in three different ways. First, a company can voluntarily recall a drug because it believes that the drug is defective or poses a risk of harm to consumers. Second, the FDA can request that a company voluntarily recall a drug for one of those same reasons. Finally, the FDA has the authority under federal law to require that companies recall drugs in some situations. Most drug recalls, however, are voluntary, not mandatory.
Once a recall occurs, the FDA evaluates the actions of the company to implement the recall and the severity of the recall, the FDA will assess whether the company has adequately notified the public of the recall, if needed, or taken enough steps to properly implement the recall. For instance, a company may pull a defective drug from the market and send notifications to the consumers who purchased the drug. Companies also may notify the offices of doctors who prescribed the drug to their patients.
However, if the FDA thinks it is necessary, it may issue a more public notification of the recall, such as by posting a notice on its website and notifying media outlets. Consumers also can sign up on the FDA website to receive periodic emails and alerts about recalled drugs and other products.
The FDA also categorizes the recalled drug into one of three classes of drug recalls
based on the risk of the defective or dangerous drugs. Every week, the FDA publishes an enforcement report that lists all the recalled drugs and the class that the FDA has assigned to the drug. If a company recently recalled a drug and the FDA has not yet classified the drug, the enforcement report just lists the drug as “recalled,” but “not yet classified.” This report allows consumers to have the most updated information on recalled drugs possible.
Rates of Drug Recalls
According to FDA enforcement report data, there were 2,163 total drugs recalled in 2019. Of that total number, 513 were Class I recalls, 1,500 were Class II recalls, and 150 were Class III recalls. In the first eight months of 2020, the FDA reported 797 recalls, including 78 Class I recalls, 648 Class II recalls, and 71 Class III recalls.
These statistics indicate that Class II recalls of drugs are more common than the other two classes. While Class II recalled drugs are those that could cause consumers a slight risk to their health or a temporary, treatable adverse effect, the FDA does not consider those drugs to be a risk of severe harm or death to consumers who use them. The possibility of Class II recalls causing any serious adverse health consequences is remote.
Learn More About How Drug Recalls Can Affect Your Legal Rights
If you have suffered an injury due to taking a dangerous or defective drug, you may have a right to compensation. You likely will have many questions about how drug recalls can affect your legal rights and the attorneys and staff at Ben Crump Law, PLLC are here to give you answers.
Having knowledge about your rights and all potential options can help you make the decisions that are right for you and your family. We can assess whether you are eligible for compensation for your injuries and help you understand the avenues of relief that may be available to you.
Call (800) 959-1444 to discover more about recalls of hazardous drugs and how those recalls can affect your claim.