Understanding Drug RecallsEvery year hundreds of drugs are discovered to have dangerous properties that can cause injuries and illness to consumers. Sometimes drugs have been improperly designed, or there was an error in the manufacturing. If drugs are harmful and dangerous, consumers must be protected with a drug recall.

What is a Drug Recall?

Once a drug has been approved by the FDA and placed on the market, it should be rigorously monitored to ensure there are no unforeseen problems. Sometimes after a drug is released, there is either a defect in the design or in the manufacturing of a drug that can cause injury or illness to individuals taking the drug. A drug recall pulls a prescription or over-the-counter medication off the market because it poses some type of risk to consumers. Drug recalls are either voluntarily instituted by the drug manufacturer or are made by the Food and Drug Administration (FDA).
A number of factors can lead to a drug recall. If a drug has improper warning labels or instructions or is packaged poorly, it may be pulled off the market. Drugs may also be recalled if, as designed, they pose health risks to consumers. In addition, contamination of drugs during the manufacturing process can also lead to a recall.

FDA Drug Recalls

When there have been a number of reports of adverse effects caused by an over-the-counter or prescription drug, the FDA can institute a recall which removes the drug from the market in order to keep consumers safe. All drug recalls should be taken seriously, but the FDA places voluntary and mandatory recalls into one of three categories:

  • Category I—is the most urgent type of recall and means that the use of or exposure to the recalled drug is likely to cause a serious health issue or even death
  • Category II—is an intermediate threat level recall and means that the use of or exposure to the drug will not cause a serious health issue but may cause temporary or medically reversible health problems.
  • Category III—is the least serious type of recall and means that, while there may be a problem with the drug, it is not likely to cause an adverse health issue.

While the FDA issues recalls, it is ultimately the responsibility of pharmaceutical companies to ensure that their products are safe. To find out more information about drugs that have been recalled, you can visit the FDA’s drug recall database.

Contact an Experienced Attorney

If you’ve been injured by a dangerous or defective drug, you should have an experienced personal injury attorney evaluate your case. At Bonina & Bonina, P.C., we have over 50 years of experience helping injured New Yorkers. Contact us online or call us at 1-888-MEDLAW1 to schedule your free consultation. Home and hospital visits are available. Se habla español.