What to Do If a Drug You’re Taking Is Recalled

When patients take over-the-counter drugs or medications prescribed by doctors, they never anticipate the drugs might cause them serious harm. Unfortunately, drug manufacturers make mistakes. Sometimes mistakes are slight, such as detached needles on syringe kits for diabetics. In other cases, drug defects can cause severe health effects and wrongful death. If a manufacturer has recalled a drug you are taking, here is what you need to know.


First, find out the reason for the recall. The drug manufacturer or the U.S. Food and Drug Administration (FDA) may issue a recall based on something that makes it unsafe to consumers. This may be due to dangerous side effects, improper consumer use that can cause serious or fatal injury, contamination during manufacture, or a manufacturing error that produces unsafe drugs. The FDA may also recall a drug if a safer alternative is discovered.

The FDA may have issued a recall because the drug company included confusing dosage instructions. In other cases, the manufacturer or supplier may have mislabeled the box entirely, and what you are actually taking is not the drug you thought you were taking. This kind of mistake can have fatal consequences if you are taking other drugs that have an adverse reaction to the drug in the box. Once you learn the reason for the drug recall, find out the danger category of the drug.


While all recalls mean that the drugs are unsafe, there are different levels of danger to consumers. The FDA groups recalls into five different categories depending on the severity of the danger that the product poses to consumers:

  • Class I. A Class I recall is the most serious. It means there is a reasonable probability of serious health issues or death to consumers who use or are exposed to the drug.
  • Class II. This class of recall means there is a remote risk the drug can cause serious health problems. It can also mean that use of or exposure to the drug can cause reversible or temporary health problems.
  • Class III. The FDA uses Class III to describe recalls in which it is unlikely that the drug causes adverse health effects.
  • Market withdrawal. If a drug has a minor problem, the manufacturer may remove it from the market. The FDA is typically not involved in market withdrawals, as it is not usually a sign of a problem with the drug itself, but rather an aftermarket issue (such as distributor tampering).
  • Medical safety device alert. In some cases, consumers consider medical safety device alerts recalls. In these cases, the manufacturer deems that a medical device poses an unreasonable risk of causing substantial harm to patients.


Contact an attorney right away if you believe that you have a case against a drug company for taking a recalled drug. Drug recalls fall under the field of law that encompasses product liability. While similar to other defective product claims, drug recalls and other pharmaceutical-related injury claims have several unique features. Your case will take one of three main types of pharmaceutical-related injury claims:

  • The manufacturer created the drug with a defect.
  • The drug has a dangerous side effect.
  • The manufacturer improperly marketed the drug.

Your particular case may include more than one type of injury claim, such as if the manufacturer failed to warn consumers of a dangerous side effect. Your attorney will investigate your claim and identify the correct defendant in your case. As a consumer who trusts drug companies to produce safe medications, a recall can be frightening. Do not panic. Visit a doctor, and call your local Philadelphia injury lawyer for expert care and legal assistance.