Anatomy of a Drug Recall

March 2, 2021 -

Drug recalls are more common than many consumers realize, and in most cases present little to no immediate danger to anyone. While common recalls might sound like a bad thing, it’s a sign of rigorous quality checks that look for issues ranging from minor packaging errors to serious health threats. The U.S. Food and Drug Administration (FDA) and drug manufacturers follow a series of careful steps to protect patients should a recall become necessary.

Recalls occur when there is a problem with a drug product or its packaging. The recall process includes a health hazard evaluation to determine if the problem presents a danger to patients. Drug recalls can fall into one of three classes:

Class I recalls are rare. In a given year, most or all recalls will fall under Class II or Class III.

The FDA and/or drug manufacturer can identify problems with a drug in several different ways. These include:

While the FDA has the power to request a drug recall, it cannot force once. All recalls must be initiated by the drug’s manufacturer. This may occur when the manufacturer identifies a problem and takes steps to report and correct it, or after the manufacturer has received an FDA request to begin the recall process. While a bill was introduced to the U.S. Senate in 2020 that would give the FDA power to issue mandatory recalls, it has not been signed into law.²

The drug manufacturer is responsible for issuing notice of the drug recall. Often, this is done by sending a letter to entities that include wholesalers, distributors, healthcare facilities, and/or pharmacies that may be in possession of or may have distributed the recalled product. The letter will include the nature of the recall, details of the product (such as the product’s name, affected lot numbers, and a description of the product and/or its packaging), and next steps. Public notice may or may not be necessary, depending on the severity and scope of the recall. If public notice is issued, the FDA typically shares a copy of the recall notice on its website.

If patients may be affected by a recall, it is the responsibility of the dispensing pharmacy or healthcare facility to notify them. That’s because only the dispensing pharmacy or healthcare facility has visibility into the lot number and expiration date of the product that the patient received. Typically, drug recalls only involve a few lots of medication from a single manufacturer. Targeted communication helps avoid creating unnecessary fear or worry for patients who did not receive the recalled product.

The specific steps patients need to take when a drug is recalled will vary depending on the nature of the recall. They may include:

Sometimes, patients will need to stop taking the recalled medication immediately. However, there are instances in which discontinuing the medication can cause more harm than good, and the patient may be advised to talk to their prescriber before making any changes.

In the event a manufacturer recalls medication, we reach out to members who are impacted to notify them of the recall and walk them through next steps. Global Reach Health identifies these members by checking order histories against the lot numbers and expiration dates of the recalled product. This allows us to determine which members may have the recalled medication on hand.

We also use our website, globalreachhealth.com, to share important information with members when a recall has a significant impact. Examples include widespread recalls – such as the extensive recall of valsartan products due to nitrosamine impurities with the potential to cause cancer that occurred in 2018-2019

– or Class I recalls that present a significant danger to patients. We also have pharmacists available 24 hours a day, seven days a week, to help members who have questions about their medications.

Global Reach Health is dedicated to providing clinically sound prescription benefits. We are here to support members and plan sponsors in navigating the drug marketplace.

1 – "FDA’s Role in Drug Recalls." U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-recalls/fdas-role-drug-recalls

2 – "Peters Introduces Bill to Grant Food and Drug Administration Needed Authority to Recall Unsafe Drug Products, Protect Consumers." U.S. Senate Committee on Homeland Security and Governmental Affairs. https:// www.hsgac.senate.gov/media/minority-media/peters-introduces-bill-to-grant-food-and-drug-administration-needed-authority-to-recall-unsafe-drug-products-protect-consumers