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Tufts Public Health

Why Was My Medicine Recalled?

“The manufacturer may discover potential contamination, defects or other problems in the packaging, or other evidence that the drug is out of its manufacturing specification,” said Paul Beninger. Photo: ingimage
Monday, December 2, 2019

When drug recalls appear in the news, they often incite concern and confusion among consumers. What does a recall mean? Why is the product being recalled now?

While it may seem that there has been a recent spate of drug recalls in the United States—including Zantac, a generic for Xanax, and medications for high blood pressure and allergies—recalls are actually relatively common. According to the Food and Drug Administration, there were 126 drug recalls in 2018 alone.

The FDA may request a manufacturer issue a recall when a product isn’t meeting its manufacturing specifications—the package labels are in the wrong language, the number of pills in a blister pack is wrong, or a foreign substance is detected, for example. This differs from a product withdrawal, which permanently removes the drug from the market because new information shows that it is more harmful to patients than it is beneficial.

So, how do the FDA and pharmaceutical companies determine when a medication should be recalled? Where does this information come from, and what are the processes in place to ensure that medications on the market are safe to use?

Paul Beninger, an associate professor in the Department of Public Health and Community Medicine at Tufts School of Medicine, studies regulatory science, drug and vaccine safety, and pharmacovigilance. Prior to Tufts, Beninger, who has an M.D. and an M.B.A., worked at the FDA and in the pharmaceutical sector in several different capacities, including pharmacovigilance.  

Tufts Now spoke with Beninger to find out more about how drugs are monitored after they have been put on the market and what to make of what’s in the news.

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