FDA Drug Recalls: What Should You Do?

FDA drug recalls

In 2019, 92 drugs were recalled by the Food and Drug Administration (FDA). This happens when the agency finds harmful chemicals or impurities in prescription and over-the-counter (OTC) drugs in order to advise consumers of the risks. 

How will I learn about a recall?

A recall may arrive in the form of a call, letter, or email, or some combination thereof. The notice will come from the FDA, the drug manufacturer, your prescribing doctor’s office, or your pharmacy. You may even learn about the recall in the news in addition to being contacted directly. 

There are three levels of FDA recalls according to how dangerous the affected medication is:

  • Class I: A dangerous or defective product that could cause serious health problems or death. 
  • Class II: A product that might cause a temporary health problem, or pose a slight threat of a serious nature. 
  • Class III: A product that is unlikely to cause any adverse health reaction, but that violates FDA labeling or manufacturing laws. 

How do I check if my drug has been recalled?

To check if your drug has been recalled, gather the following information:

  • The drug’s name (both generic and brand name)
  • The dose
  • The manufacturer’s name
  • The lot number 

The information that will be hardest for you to find is the lot number. It can usually be found near the expiration date, the barcode, or the directions for use. 

If you can’t find the lot number, your pharmacy will be able to provide you with the information. 

What do I do if my drug is recalled?

Do the following if your drug is recalled:

  • Call your pharmacist. Your pharmacist should be able to refill your prescription from a lot number that has not been recalled. If the recalled drug is OTC, they may be able to recommend a safe alternative. 
  • Call your doctor. If they don’t contact you first, call your doctor’s office in addition to your pharmacist. While your pharmacist can recommend a replacement, you should only change drugs at your doctor’s discretion. Pharmacists understand how drugs work, but they don’t know your health history the way your doctor does. 

What should I NOT do?

Here’s what not to do if your drug is recalled:

  • Don’t flush the drugs down the toilet. The drugs will dissolve and poison the water in your community, potentially causing illness in your friends, family members, and neighbors.   
  • Don’t leave them in the medicine cabinet. If you leave the recalled drugs in a place that is easily accessible, you or someone else may forget about the recall after some time and start taking them again. 
  • Don’t immediately stop taking the medication. You should always call your doctor before you stop taking a prescription medication in case you may suffer from adverse withdrawals or worsening symptoms. 

Pharmacies generally have a return and refund policy for drugs that have been recalled. This option is best because you get your money back, and the pharmacy can dispose of the drugs in a safe manner. If the recall is a Class I recall, the drug manufacturer will provide specific instructions. 

Why are drugs recalled?

The FDA may recall drugs if the agency finds impurities and human carcinogens which are known to cause cancer. Two carcinogens that often trigger recalls are N-Nitrosodimethylamine (NDMA) and dimethylformamide (DMF). 

Recently, NDMA was found in the heartburn/GERD medication ranitidine/Zantac. The drug was pulled from pharmacy shelves, and patients taking the drug were notified by the manufacturer. 

Visit the FDA’s complete list of recent drug recalls to check if your drug has been recalled. 

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