411: Drug Recalls & Consumer Safety

How to make sure your medication has not been recalled, and what to do if it has.

Caitlin Hoff is health and safety investigator with ConsumerSafety.org, CDC Certified: Health Literacy for Public Health Professionals.

This past summer, major news coverage was dedicated to the U.S. Food and Drug Administration recall of a common generic blood pressure medication. With more than a third of our country living with high blood pressure, this was a troubling recall for many Americans. It also raised a great number of questions surrounding drug safety in the wake of the FDA announcement. To answer some of those questions, here is what you should know about consumer drug recalls.

A drug recall can be voluntarily issued by the manufacturer if they discover a problem with their product or issued by the FDA if credible evidence of a problem is found. Regardless of where the recall originates, most drugs are recalled for one of five main reasons:

• If a drug poses a previously unknown health risk to consumers, it’s safe to say that it will be recalled. While all medications come with potential side effects, the health benefits should outweigh the risks.
• A drug may be recalled if the labeling or packaging is misleading or faulty. Because patients are typically self-administering prescription drugs at home without the help of a doctor, the instructions and packaging need to be easy to read and understand. If not, it may threaten the health of patients by creating more instances for user error.
• If a drug or its ingredients have been contaminated, like with processed food items, a recall will be issued. This was the reason for the recalled blood pressure medication this past summer. Several manufacturers of the drug’s active pharmaceutical ingredient (API) valsartan, found carcinogenic impurities in their ingredient supply. Drug companies that bought from those specific manufacturers were included in the recall.
• A drug will be recalled if it is mislabeled. This summer gave us an example of this reason as well when a supply of a diuretic used to mainly treat congestive heart failure was mislabeled as a blood pressure medication. This sort of labeling mix-up can greatly affect a patient’s recovery or maintenance of a serious health condition.
• If a drug’s quality is negatively affected by a manufacturing issue, it can be cause enough for a recall. The drug’s quality must meet certain standards to ensure effectiveness and safety for patients.

If you believe you might be taking a medication that has been recalled, it’s important to double-check. The FDA will publish a list of all affected medications; you can compare your own prescription against this list using the following identifiers:

• Company Name
• National Drug Code (NDC)
• Lot Number

If you can’t find this information on your prescription bottle, call your local pharmacist and they will be able to provide you with the necessary information.

Once you have determined that your prescription medication was recalled, consult with your doctor on the best course of action. Do not stop taking your prescription medication unless your doctor tells you otherwise. Promptly stopping a medication, even one that has been recalled, could endanger your health even more. Talk to your doctor about alternative medications and follow their instructions to safely make the shift from one medication to the other.

As you take your new medication, you should monitor your body closely for any adverse side effects from the new drug. If you experience harmful side effects or wish to report an issue with the quality of your medication, feel free to use the FDA’s MedWatch Voluntary Reporting Form. The FDA relies on these consumer complaints and critical feedback to track faulty or potentially dangerous drugs.