According to the FDA, approximately 60 drugs have been recalled throughout 2022. This means that either the U.S. Food & Drug Administration or the drug manufacturers themselves have discontinued the drug and pulled the remaining product off the market. A recall happens to ensure product quality and patient safety. But these recalls are not all due to life-threatening flaws: there are many reasons to recall a product. There are three classes of drug recalls, each indicating a different level of severity. So, let’s discuss some common reasons for a recall and what each of the three classifications are. 

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Reasons for a Drug Recall 

When a drug goes onto the market, public safety is a top concern for both the drug manufacturers and the FDA alike. Though rigorous testing is done prior to distribution, certain issues may still go undetected until after the drug is distributed. Common reasons for a recall include: 

  • Mislabeling 
  • Inconsistency in the strength of the drug 
  • Contamination  
  • Poor manufacturing 
  • Safety concerns, such as side effects or linked health complications 

If you’re concerned about the status of a medication you or someone you know is currently taking, contact the manufacturer, your healthcare provider, or a pharmacist.  

The 3 Classes of Drug Recalls

Class I Recalls 

Out of each of the three FDA classifications, the Class I recall is the most critical. These recalls are usually linked to defective products that can cause serious health problems or, in the worst-case scenario, death. An example of a Class I recall would be if a drug was contaminated with dangerous toxins. Because of the severity of this classification of recall, the FDA will monitor the situation closely to guarantee that the manufacturer takes appropriate action to protect the public’s health.  

Class II Recalls 

The most common type, Class II recalls are described by the FDA as involving “products that might cause a temporary health problem, or pose only a slight threat of a serious nature.” While Class II is not as urgent as Class I, the FDA will still take measures to oversee that the necessary recall guidelines are being met. 

Class III Recalls 

Class III recalls are for products that are unlikely to cause harm to someone’s health. The reason for a Class III recall usually involves minor product defect errors. Although the likelihood of your health being adversely affected is small, it’s still wise to follow the instructions of the recall and stop use immediately. 

Classes of Drug Recalls Legal Impact 

You may have a right to legal compensation if you’ve suffered injury or economic harm from a dangerous or defective drug. However, there are many factors that can go into a lawsuit involving recalled drugs. For instance, some recalls establish a procedure where effected consumers can request a full refund. Therefore, there’s nothing left to sue for if the extent of the damages is reflected in the purchasing price. Additionally, if the plaintiff purchased or continued to use the medication after it was recalled, it will be harder to succeed in court.  

Foley & Small: Your Defective Drug Pharmaceutical Lawyer 

Navigating a lawsuit involving any type of drug recall classification can be stressful and confusing. Armed with practical litigation experience on a state and federal level, Foley & Small will guide you through the process. Discover the next steps for what to do if a recalled drug affects you.