Understanding Drug Recalls with Dr. Ileana Elder

Q&A with FDA Podcast | Transcript

Dr. Roach: Welcome to “Q&A with FDA.” In this podcast series, we aim to answer some of the most frequently asked questions that we’ve received from the public. My name is Dr. Sara Roach, and today’s topic is drug recalls. In FDA’s Division of Drug Information, we regularly receive inquiries from health care professionals and consumers seeking more information about products that are included in a particular drug recall, the reason for the recall, and what actions to take in response.

Today we are joined by Dr. Ileana Elder, Branch Chief in the Incidents, Recalls, and Shortages Branch within the Office of Compliance in FDA’s Center for Drug Evaluation and Research. Dr. Elder, thank you for joining us today.

Dr. Elder: My pleasure.

Dr. Roach: Dr. Elder, FDA uses many tools to safeguard consumers from health risks and to mitigate harm. A drug recall is one of the most effective ways to protect the public from a defective or potentially harmful drug, and a recall may either be recommended by FDA or undertaken voluntarily at any time by manufacturers and distributors.

Dr. Elder: That’s right. A recall is a voluntary action taken by a company to remove a defective drug from the market and warn patients, consumers and health care providers about a potential risk. FDA’s role in a recall is to oversee a company’s recall strategy, assess the adequacy of the company’s action, and classify the recall.

Dr. Roach: Can you expand upon FDA’s classification of recalls, starting with class I?

Dr. Elder: Yes. A class I recall is the most serious, where there is a reasonable probability that using or being exposed to the recalled drug will cause serious adverse health consequences for a patient or a consumer. A class I recall is urgent and, in most circumstances, involves removing the drug from the market. In these situations, the consequences of a patient using the drug are immediate or long-range, and life threatening, and may involve a direct cause and effect relationship.

One example of a significant class I recall was the contamination of certain hand sanitizers with methanol, a dangerous and toxic substance. Not only did we evaluate and classify recalls to protect the public, but we also communicated to manufacturers and distributors about what they should do if they make or distribute a product that has a risk of methanol contamination. We also notified consumers via our website about hand sanitizers they should not use.

Another recent example of a class I recall in the news was the recall of certain ophthalmic products because of bacterial contamination, which led to a multistate outbreak. Products intended for use in the eye can pose a greater risk of harm because they bypass some of the body’s natural defenses. The eye infections involved are rare, extensively drug-resistant strain of bacteria, and the outbreak unfortunately resulted in eye infections, permanent loss in vision, and death. The company involved was placed on import alert to help stop their products from entering the U.S. market, and from it being distributed in the U.S. supply chain.

We acted swiftly to respond to the outbreak. We warned the public not to purchase and to immediately stop using certain over-the-counter eye drops due to the potential risk of eye infections that could result in partial vision loss or blindness.

Dr. Roach: These recalls all understandably resulted in many questions and concerns from consumers and health care professionals. Another recall that stands out in my mind, because of the number of questions it generated, is the drugs recalled due to the presence of nitrosamine impurities.

Dr. Elder: Yes. As you know, the nitrosamine-related recalls are ongoing and have been in the news for years now. To provide some background on these recalls, nitrosamines are organic compounds that we are exposed to in our everyday lives, they exist in our water and foods. But we don’t want them in our drug supply. This is because exposure to nitrosamines may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time.

Since the nitrosamine-related recalls began in 2018, FDA has requested manufacturers to withdraw certain drugs from the market due to nitrosamine impurities above the acceptable intake limits. These recalls have impacted many different types of drugs over the years. This includes angiotensin II receptor blockers such as valsartan, losartan and irbesartan, and other drugs such as metformin and varenicline.

The nitrosamine recalls are an example of a class II recall which is a situation where using or being exposed to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Most drug recalls that occur are class II recalls.

Dr. Roach: And then there are class III recalls, which are the least serious.

Dr. Elder: That’s right, a class III recall is a situation in which using or being exposed to the product is not likely to cause adverse health consequences. A class III recall could include certain concerns about minor drug labeling errors, defective packaging, or incorrect expiration dates, to name a few.

Dr. Roach: Separate from recall classification is recall depth, which can sometimes create confusion. Consumers might learn through the news that a product is recalled, but the pharmacist has not notified them about the recall, leaving them unsure of what to do. Can you describe the different depths of recalls?

Dr. Elder: I’m glad you brought this up. As you mentioned, recalls have different depths, which refers to the extent of product removal from the market through the distribution chain. The recall can be consumer or user level, retail level, or wholesale level, and this is identified in the recall notice provided to distributors and consignees by the manufacturer or distributor of a drug that is being recalled.

While this is not the same as the classification, a good rule of thumb to keep in mind, is that in general, class I recalls, the most serious, may extend to the consumer level, and that makes sense – these are the urgent situations when everyone involved with the use of a drug product should immediately stop using it.

Class II recalls may extend to the retail level, meaning the company conducting the recall is removing the product from retail stores and pharmacy shelves.

And class III recalls, the least serious, may extend to the wholesale level. This is intended to prevent any more of the recalled product from reaching pharmacy or store shelves from wholesalers because of a small potential risk.

These different recall depths allow companies to conduct drug removals at the appropriate level and ensure that patients and consumers continue to have access to drugs that do not present a significant risk to their health. If all recalls were removed to the consumer or user level, regardless of risk, this would be detrimental to public health.

Dr. Roach: Dr. Elder, you also mentioned the class of recall is determined when FDA completes a health hazard evaluation. There are probably a lot of listeners who don’t know what FDA’s health hazard evaluation includes. Can you explain?

Dr. Elder: Of course. First, recalls are typically initiated voluntarily by companies before they notify FDA. This means that companies initially develop their recall strategy, including proposing the recall depth (that is - consumer, retail or wholesale level) based on their own assessments. Once the recalling company notifies the FDA, we conduct our own review which includes a health hazard evaluation to help inform whether the company’s initial recall depth and overall recall strategy are appropriate.

The health hazard evaluation is FDA’s clinical evaluation of the health hazard, or harm to patients and consumers, presented by a recalled drug. It takes into account several factors.

One, it considers the nature of the problem and whether it can be easily identified by users. For example, is the drug potency higher than it should be and how would a normal user be able to identify this issue.
Two, it assesses intended use, including intended or likely segments of the population exposed to the recalled drug, such as pediatric patients. For example, is the drug intended to treat a specific condition or various diseases, and is it indicated for various groups or only for one distinct population segment.
Next, the health hazard evaluation looks at the likelihood of adverse events occurring. For example, is it likely or unlikely that an adverse health consequence could occur if the recalled product is used.
And finally, an assessment of the degree of health hazards, such as life-threatening, limited adverse health consequences, or no adverse health consequences at all. For example, an adverse health consequence could be likely. But the degree of health hazard could be minimal, such as a minor complaint as opposed to permanent impairment of a body structure, like loss of vision.

Dr. Roach: So, part of FDA’s role is in overseeing a company’s recall strategy, and the health hazard evaluation is part of that FDA recall process.

Dr. Elder: Right. A company develops a recall strategy and includes certain factors, such as their own health hazard assessment. The recall strategy is a planned specific course of action to be taken in conducting a specific recall. It addresses the depth of the recall, the need for public warnings, and the extent of effectiveness checks for the recall.

It’s critical for companies to be “recall ready” at all times so that they can act quickly and effectively to protect patients and consumers from harm by quickly addressing violative drugs on the market - and this involves developing a robust recall strategy.

Dr. Roach: FDA’s Small Business and Industry Assistance (or SBIA) discussed recall strategy in a podcast from the SBIA Chronicles podcast series titled “The Key Elements of Being Recall Ready.” For those interested in learning more, the podcast is linked from the episode webpage.

Let’s get into a few more parts of the recall strategy you just mentioned. Regarding FDA’s role in assessing the adequacy of a company’s action, I’d appreciate it if you’d talk about how FDA performs this assessment, and how FDA gets involved if a recall notification is inadequate.

Dr. Elder: Companies describe how they will conduct a recall effectiveness check in their recall strategy. This includes how to track and identify customers who fail to respond to recall notifications, and what additional steps the company will take to notify those customers who do not respond.

FDA evaluates the effectiveness of a recall by reviewing a company’s efforts to properly notify customers and to remove the defective product from the market. In addition to reviewing the effectiveness checks conducted by a company, FDA also may contact company’s customers to assess whether the recalling company and the customers are carrying out the recall.

If FDA's checks determine the recall to be ineffective, FDA works with the recalling company to take appropriate actions to protect patients’ health, such as re-issuing recall notifications to customers and patients if appropriate.

Dr. Roach: There has been an increase in the number of inquiries about drug recalls in the past few years. What are some factors contributing to this increase?

Dr. Elder: The number of total recall events has actually remained steady over the past few years, although the number of affected drugs in each individual recall event fluctuates year to year.

In 2023, antibacterial products had the highest percentage of recalls, followed by cardiovascular agents, ophthalmic agents or eye drops, and then respiratory tract agents. And the top three reasons for recalls in 2023 were related to manufacturing quality issues. In particular, there was an increase in recalls attributed to contamination, including foreign material or particulates in the drug, microbial contamination, product mix-ups and cross contamination, and chemical contamination.

You can view the numbers and trends over time in the reports posted in the resources section of this episode’s webpage.

Dr. Roach: Speaking of the number of recalls, can you describe for our audience FDA’s role in notifying the public of drug recalls?

Dr. Elder: Companies might notify the news media, and the FDA may issue an alert when the recalled drug poses a serious health hazard and should not be used by consumers. This is not the case for all recalls. If a company does not notify patients and consumers after FDA makes a recommendation that they should, the agency may issue a press release or an alert, or post on social media to protect patients and consumers.

Dr. Roach: In addition to the types of notifications you just described, FDA makes recalls public in a report that covers recalls for FDA-regulated products, known as the FDA’s Enforcement Report.

Dr. Elder: That’s correct. All recalls that are monitored by FDA are included in the enforcement report, which is available on FDA.gov. This report also includes the recall classification, if the recall has been classified by the agency, which again is based on the level of hazard.

Some recalls are listed in this report as pending or “not yet classified.” This is a means to alert the public sooner when a company initiates a recall, and these listings are updated with the class of the recall once FDA completes review of the recall information provided by the company and a health hazard evaluation.

Dr. Roach: We’ve noticed a new trend of insurance companies and health plans sending recall notices and letters to consumers when the recall is not at the consumer level. We have found that most of these recalls were conducted at the retail or wholesale level, and within the letter it will confirm that no action is needed on the part of the consumer.

Dr. Elder: I’ve heard about this practice and understand it can be confusing. But patients and consumers should contact their pharmacy with any questions. This is important especially in those situations where the recall depth is not to the consumer level and it would be more harmful to stop using a drug unnecessarily.

Dr. Roach: Another confusing situation is when Dear Health Care Provider letters are issued rather than a recall notice. How can health care professionals tell the difference between these?

Dr. Elder: Dear Health Care Provider letters are intended to alert physicians and other health care professionals about important new or updated information regarding a drug. Often these letters are in the form of a mass mailing or email from the manufacturer or distributor, or from FDA. Sometimes, these letters notify health care providers about an issue with a drug, along with instructions on how to address or correct an issue. In these cases, the drug can continue to be used as long as the specific instructions from the manufacturer are followed.

A drug recall notice on the other hand, is a notification of product removal that includes the product defect, the associated health risks, and specific instructions for how to dispose of the recalled defective drug. A recall notice is distributed by the recalling company at the appropriate depth, (to consumers, retailers, or wholesalers) and this recall depth will be included on the recall notice.

For example, if a health care provider becomes aware of a recall notice regarding a drug recall to the wholesale level, which is the lowest health risk recall situation, the health care provider may continue to provide or prescribe the product to patients.

As always, we recommend that health care providers and the public contact the recalling company and the FDA if they have questions about a particular recall situation.

Dr. Roach: Even though most recalls are voluntary actions, and conducted on a company’s own initiative, or by FDA request, can you explain when FDA can use statutory authority to order a company to recall a drug?

Dr. Elder: Of course. And I think that there is confusion around this because FDA has mandatory recall authority for foods and other commodities, including medical devices, certain biologics, tobacco, and cosmetics - meaning that the FDA can order a company to conduct a recall for those products.

But for most drugs, a recall is a voluntary action. That’s why in most recall notices you’ll see a statement that says, “This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.”

One exception is when the drug in question is a controlled substance. The FDA has authority to mandate the recall of controlled substances when a company does not voluntarily take this action - but only if there is reasonable probability that the drug will cause serious adverse health consequences or death, meaning a class I situation. Then FDA may issue a mandatory recall order for the controlled substance to the responsible firm.

Dr. Roach: Dr. Elder, I’m sure our listeners would appreciate some practical tips for staying up to date with drug recall news.

Dr. Elder: The best source of information for patients and consumers is on our “Drug Recalls” page on FDA.gov, which will be linked on this episode’s webpage. There, you will find a list of company press releases mostly for class I recalls. When a company announces a recall, market withdrawal, or other safety alert, we post that announcement in this database. You do have to keep in mind though that not all recalls have press releases or are posted on this webpage.

On this webpage, you can find additional links to more information about other recalls for other FDA-regulated products, as provided on the Recalls, Market Withdrawals, & Safety Alerts webpage or the enforcement report we mentioned earlier.

Dr. Roach: We usually recommend health care professionals sign up to receive direct notifications about recalls, so they know real-time about news and updates. Is that your recommendation as well?

Dr. Elder: Yes, and there are many options to do this depending on how individuals like to receive information. If you like to use your email to receive alerts, you can sign up for FDA’s recall email alerts. The link to subscribe is available at the top of our Recalls, Market Withdrawals, & Safety Alerts webpage.

Subscribing to emails alerts from the MedWatch webpage is also helpful.

Or if you prefer to receive your information via social media, you can follow “FDA Recall Information” on X.

Dr. Roach: The questions we receive most frequently from patients and health care professionals are not because they are unaware of a drug recall, but instead, they are calling us because they aren’t sure what to do next. In addition to checking FDA.gov for a company’s recall announcement, what else do you advise?

Dr. Elder: If the return or product disposal instructions are unclear, patients should talk with their pharmacist. If you’re the pharmacist and the return instructions are unclear, contact the manufacturer or FDA. In some cases, you may need to check with your state board of pharmacy or company policy.

If you’re the prescriber, you may be asked to prescribe an alternative medication or write a new prescription to replace a returned product.

Dr. Roach: We have a lot of health care professionals listening to this podcast. What is your final message for them about managing drug recalls?

Dr. Elder: First and foremost, stay informed. Health care professionals are essential in reassuring and guiding patients when a drug is recalled, and they can encourage patients not to panic and help them understand what the recall notice is saying, along with what they should do.

Health care professionals can be active participants with substantial impact on ensuring the safety of the drug supply. For example, they can continue to assist the FDA when we conduct recall audits via phone calls or email to verify that companies are appropriately conducting a recall, or they can submit MedWatch reports to the FDA when they become aware of adverse events related to a drug.

Dr. Roach: And that link to the MedWatch reporting page is also linked from our episode webpage.

Thank you again Dr. Elder for all this great information. We appreciate your time today explaining drug recalls. And thanks to our audience for listening to “Q&A with FDA.” The full podcast and transcript of this recording is available at fda.gov/qawithfda. Many of our episodes offer continuing education credits for health care professionals, so be sure to visit fda.gov/qawithfda for more details. If you’re looking for additional learning or continuing education credit opportunities, including live and home study webinars, you’ll also want to check out fda.gov/CDERLearn and fda.gov/DDIWebinars. And if you have questions about this episode, or anything drug-related, email us at druginfo@fda.hhs.gov.

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