Drug Recalls And Your Medical Provider: What If You Don't Find Out About A Defective Medication?

Posted on: 21 December 2015

Your doctor has been treating you for a specific health issue for some time, and as part of that treatment, you've been taking medication. 

But after you've been taking the medication for some time -- perhaps months or even years -- you learn that the drug was recalled by the U.S. Food and Drug Administration (FDA). Have you been harmed, and what should you do now?

Reasons for Recalling a Drug

The FDA can recall a drug for many reasons, including that it has not been properly approved, it is contaminated during or after manufacture, or new research has shown that the drug's safety may be in question.

A recall can also be initiated by either the drug's manufacturer if they believe that there may be some danger associated with taking the medication. There are different types of recalls depending on the severity of the problem with the product, including:

  • Class I recall. Using the drug could cause you serious harm or even death.
  • Class II recall. Using the drug could cause serious health problems, but most effects will be temporary.
  • Class III recall. Using the drug probably won't cause any issues, but there may be a risk.
  • Market withdrawal. These are usually initiated by the manufacturer because of some problem with, for example, the packaging or the method of delivery, and not with the actual medication.

You are more likely to be concerned with Class I or II recalls because of the chances of a severe or moderate health risk.

Who Has the Responsibility to Notify You?

The biggest problem with drug recalls is that there is no foolproof way to notify individual patients about a drug recall. If your medication has been recalled, there are a few ways that you might be notified. 

  1. The first is through the FDA directly. Since July 2011, the FDA has run a program that will notify users about a recall or potential issue. However, the FDA doesn't keep track of your specific information; instead, they contact the customers that purchased the drug for resale, like pharmacies.
  2. Manufacturers of a defective drug have the legal responsibility for notifying patients, but the FDA does not require them to do so. 
  3. Your doctor's office may keep track of recalls so that patients can be informed. 
  4. Your pharmacist should be a source of information on recalled drugs.
  5. Many patients find out about recalls through the news media, although for less-common drugs, these aren't well publicized.

What if You Were Harmed by a Drug?

If you have been taking a drug safely and you begin to have reactions or side effects for any reason, contact your medical professional immediately. You and your doctor can work together to find out if there is a recall and/or report the problem to the FDA for them to look into. The FDA also has a form on its website at fda.gov where you can report problems with drugs or medical devices. The most important thing you can do is take care of your health and do what your doctor advises based on your symptoms.

Do note that the FDA and your personal physician are unlikely to carry any responsibility for a drug that has caused injury to you. If you suffered some harm because of a contaminated or unsafe medication, the manufacturer carries the highest legal responsibility. Contact a personal injury attorney to discuss your case and determine if you can file a lawsuit.