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What Happens When a Drug Is Recalled?

The FDA’s drug recall system is meant to protect consumers, but inspection blind spots, manufacturing lapses, and slow communication can leave dangerous medications in circulation for months

Kristel Tjandra, Ph.D.

August 27, 2025

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On June 27, 2024, Mary Louise Cormier, age 91, was admitted to the MaineHealth Mid Coast Hospital Emergency Department in Brunswick, Maine, after showing signs of lethargy and minimal responsiveness. According to her daughter, Cormier had taken generic 750 mg potassium chloride capsules just two days earlier. The medication is commonly prescribed to patients with low potassium levels to help with their nerve and muscle function.

When Cormier’s test results came back, her doctor noticed an unusually high level of potassium in her blood; high enough to trigger cardiogenic shock, a condition in which the heart can’t pump enough blood to vital organs. According to a case report, Cormier’s doctor ordered the test to be re-run and confirmed that the dangerous levels were due to a defect in the potassium chloride drug. Cormier never recovered from her cardiac arrest and passed away the next day.

Weeks after Cormier’s death, her family learned that the potassium chloride capsules she took were made by Glenmark Pharmaceuticals, an India-based manufacturer with U.S. headquarters in New Jersey. The company, which supplies more than two dozen medications in the U.S., had recalled nearly 47 million capsules; though its actions came in stages. In May 2024, Glenmark quietly notified wholesalers, but it wasn’t until June that it publicly acknowledged that the medication, typically taken with water, failed to dissolve properly — a potentially deadly flaw.

In the same announcement that appeared on the FDA website, the company wrote, “Glenmark is notifying its wholesale and distributor customers by written letters and is arranging for return of all recalled batches… Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.”

Cormier’s daughter claims that the actual consumer recall notice didn’t reach patients like Cormier until weeks after the initial announcement. In a class action complaint against Glenmark, Cormier’s daughter says “her death was, therefore, entirely avoidable — had Glenmark not sold defective drugs in the first place and had Glenmark promptly communicated to patients to avoid them.”

According to a ProPublica investigation, the Food and Drug Administration (FDA) had long been aware of manufacturing issues at Glenmark’s facilities in India. In the year leading up to the potassium chloride recall, the company had issued four other voluntary recalls. Yet neither the FDA nor the manufacturer took immediate action to prevent more defective drugs from reaching the U.S. public.

As a gatekeeper for drug safety in the U.S., the FDA is often in the spotlight as the weak link, but “every player that has a hand in the [drug] supply chain is all responsible,” says Melissa Sayers, M.S., a drug regulatory manager at Registrar Corp who advises companies on complying with FDA regulations and submitting regulatory information. “Whether it’s labelling or packaging… they all have to follow the regulations. And if at any point in that step, something’s wrong, they should be taking action.”

Yet the recall process is so complicated that it frequently delays the safeguards regulators intend to put in place.

Inside the Drug Recall Process

By the FDA’s definition, a drug recall is a voluntary action by a company to remove any defective medications from the market and warn people of their potential harm.

Contrary to what many assume, the FDA’s regulatory authority allows it to request — but not mandate — a company to remove a drug from the market (the only exception to this is when the drug is a controlled substance). However, if a company refuses to cooperate or fails to address the concerns, the FDA can pursue legal action under the Food, Drug, and Cosmetic Act.

“People often talk colloquially about the FDA ‘pulling the drug from the market,’ and in almost all instances, the answer is no, the FDA didn’t pull the drug from the market. The manufacturer pulled the drug from the market, and the FDA simply made it untenable for the manufacturer to behave otherwise,” says Caleb Alexander, M.D., an internist and epidemiologist at Johns Hopkins University who researches prescription drug safety.

Most recalls start when a manufacturer discovers problems during stability testing or other routine quality-control checks. According to the FDA’s guideline, a drug stability test should be conducted at least once a year, and ideally every quarter in the first year. This self-reporting should be no less reliable than an FDA-initiated recall, says Dr. Alexander, so long as companies uphold their legal and ethical responsibility to follow agency standards.

“Do manufacturers have an incentive to game the system and bend the rules? Well, they may. But they also have an incentive not to, [given the] significant financial and legal penalties for bad behavior,” he adds.

According to a 2024 study, a single recall can cost a company $10 to $25 million in lost sales. Others have even quoted upwards of $600 million.

While recalls can be serious, it’s also important to keep them in perspective: Each year, more than six billion prescriptions are dispensed across the country, and about 17,000 drug products have been recalled since 2011 for various reasons. Because certain adverse events or unanticipated problems with a medication aren’t always identified within the timeline of its clinical trials, the FDA requires that manufacturers monitor and maintain a record of any adverse events for 10 years after the drug product enters the market.

“I think it’s amazing that we don’t have a million people dead every year from a product failure,” says Joey Mattingly, Pharm.D., Ph.D., a pharmacist and professor of pharmacotherapy at the University of Utah. To him, these numbers demonstrate the significant contribution of a functioning regulatory body. “When things are quiet and there’s no major issues — that’s the FDA.”

However, even when a manufacturer works fast to pull a drug, the process is far from immediate. “Just because the spigot is turned off and shipments may be shut down from manufacturers, doesn’t mean that the products may not remain available on the market through pharmacies for some period of time,” adds Dr. Alexander..

Missed Inspections and Weak Quality Control: The Hidden Drivers of Drug Recalls

Sterility lapses are the leading driver of drug recalls, accounting for 37% of all FDA recalls between 2012 and 2023. Such failures can allow harmful microbes to contaminate medications through unclean equipment, packaging flaws, or mishandling in transit.

In theory, adherence to the FDA’s current good manufacturing practice (cGMP) regulations should safeguard against most quality problems like sterility issues. In practice, however, there have been instances when manufacturing facilities — both foreign and domestic — have repeatedly fallen short of these requirements.

“Most recalls reflect a breakdown in manufacturing quality control or supply chain oversight,” says Karina Rudenberg, PharmD, an emergency medicine clinical pharmacist at Northwest Community Hospital in Arlington Heights, Illinois. “The Glenmark Pharmaceutical’s recall is a fairly standard example of this.”

She adds that overseas manufacturing problems often go undetected longer than domestic plants — a weakness of the current voluntary recall process, where the responsibilities rest heavily on the manufacturers, and where the FDA has more limited oversight.

Glenmark is a recurring example. In July 2025, the FDA issued a warning letter to the company, stating that it repeatedly violated the FDA’s cGMP regulations at its manufacturing facilities in India. “These repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs is inadequate,” the agency wrote. According to an investigation by ProPublica, the FDA had not set foot in Glenmark’s facilities in India for more than four years before reporters exposed the problem.

Cutting Costs Overseas, Losing Quality in the U.S.

Drug manufacturing began shifting overseas in the early 1970s as companies sought to cut labor and other overhead costs. But the move created new challenges for quality control, as the FDA struggled to extend its oversight beyond U.S. borders. By law, domestic facilities must be inspected every two years. Yet well into the early 2000s, there were still no formal requirements for how often foreign plants had to be inspected.

In 2012, then-President Barack Obama signed into law the Food and Drug Administration (FDA) Safety and Innovation Act, which allowed the agency to recognize inspections conducted by a foreign government as a way to increase the frequency of inspections. The mutual agreement between the FDA and foreign regulatory authorities is currently valid in the European Union, Switzerland, and the United Kingdom. The FDA has also established offices in China, Europe, India, and Latin America to expand its foreign inspection capacities.

Before the COVID-19 pandemic, the FDA was conducting approximately 3,000 foreign inspections in more than 90 countries, with about a third of these inspections focused on drug products. By 2019, the number of foreign drug inspections had increased to a level that almost matched that of the domestic inspections.

But inspections plummeted after the COVID-19 pandemic. In 2019, the FDA conducted 1,391 drug-related inspections in the U.S. and 1,205 overseas. Last year, the numbers were still low, at 960 and 899, respectively. According to a Government Accountability Office report, this decline is due to the lack of staff, an issue that, according to some, will likely persist in light of the ongoing federal budget cuts.

But lack of inspection is not the only problem. In 2022, the Office of Inspector General, a division of the U.S. Department of Health and Human Services, wrote in a report that, “[the] FDA did not always follow its policies and procedures for foreign for-cause drug inspections… and could not provide documentation to support that all lead investigators completed the required training before they conducted inspections.” A “for-cause inspection” refers to a situation when the agency has a reason to believe that there are problems in a facility. This delay in follow-ups jeopardizes the efficiency of correcting any regulatory deficiencies.

In addition, most foreign facilities are given up to 12 weeks notice about an upcoming inspection, whereas domestic inspections are usually unannounced. Still, the FDA found deficiencies in 66% of foreign inspections — twice as high as domestic inspections — according to Rep. Morgan Griffith, R-Va, at a Committee on Energy and Commerce hearing in 2024.

In May 2025, newly appointed FDA Commissioner Martin Makary, M.D., announced the agency’s intention to end this “double standard” by expanding unannounced foreign inspections. At the time of publishing, the FDA had not outlined a specific plan to improve the timeliness and frequency of foreign inspections. However, a source at the agency told MedShadow that, “The FDA remains committed to upholding gold standard science and common-sense practices. We are actively working to strengthen and expand our foreign inspection program, as outlined by Commissioner Makary. Ensuring the safety and efficacy of the nation’s drug supply remains a top priority.”

How Recalls Are Classified

Depending on the potential risks, the FDA assigns drug recalls into three classes based on its health hazard evaluation:

A Class I Recall — the most serious type — is issued when the drug in question could cause serious health issues or even death. The potassium chloride recall by Glenmark is a prime example of this. The methanol contamination found in hand sanitizers distributed during the COVID-19 pandemic is another.

A Class II recall, which is less severe, refers to recalls of drugs that could cause temporary or reversible side effects. A recent example is the June 2025 recall of a thyroid medication, levothyroxine sodium, because it was found to be less potent than expected. According to a study by Dr. Mattingly and colleagues in 2022, about 80% of drug recalls in the U.S. are considered Class II recalls.

A Class III recall, the least severe type, is issued when the drug is unlikely to cause adverse effects but still fails to meet the FDA’s current good manufacturing practices (cGMP) and safety standards. For example, the antiviral tablets Famciclovir were recalled in June 2025 after a hair strand was found attached to a pill inside a sealed bottle. Other common Class III issues include packaging errors, mislabelling, or incorrect expiration dates.

Depending on the severity of the risks, drug recalls can take place at either the wholesale, retail, or customer and user level. A Class III recall, where the health risk is minimal, may reach only the wholesalers with a focus on preventing further product distribution to pharmacies and retailers. A Class II recall may include both wholesalers and retailers, where the drug is pulled from the pharmacy shelves. Whereas a Class I recall likely extends all the way to the customers, urging them to stop using the drug immediately.

As a general rule of thumb, the more severe the recall, the more likely that the recall notification will extend to the customer level.

“That makes sense — these are urgent situations when everyone involved with the use of a drug product should immediately stop using it,” says Ileana Elder, the branch chief of the FDA Office of Compliance, in an FDA podcast interview.

Why You Might Never Hear About a Recall

The voluntary nature of recalls allows companies to initiate the process, developing their own strategies before notifying the FDA. These strategies outline the depth of the recall and how the public will be informed.

While manufacturers are required to notify the FDA within 15 days of detecting an adverse event, compliance with this notification or the timeline is uneven. A 2015 JAMA Internal Medicine study found nearly 10 percent of reports missed the deadline. With no penalties for late reporting, inconsistencies in how quickly companies alert the FDA can abound.

Once a company notifies the FDA, the agency reviews the company’s recall strategies and works together with them to determine the next steps. Recall strategies includeplans for notifying the appropriate parties about the recall and how to remove the products effectively. The FDA also conducts its own health hazard evaluation, which is an assessment of the severity of the health risks and who will be affected by the product in question. This assessment informs the FDA of the appropriate classification for the recall (Class I/II/III).

While waiting for the FDA’s assessment, a company can issue an alert to protect patients and consumers from defective products. These notices, which are decided on a case-by-case basis depending on the health risks, might take the form of phone calls, or physical or electronic letters to wholesalers, pharmacies, or consumers, outlining the steps to take. Companies may also contact the media to reach a wider audience.

While federal regulations (21 CFR § 7.49) specify what these recall communications must include, they do not explain how the FDA itself chooses its notification methods, such as when to rely on press releases, its public database, or other channels.

Because most recalls fall under Class II, notifications often stop with wholesalers and pharmacies rather than reaching patients directly.

If consumers are not notified, pharmacies can extend the communication to those in their community by phone or mail.

“There are multiple layers of communicating a drug recall,” explains Dr. Mattingly. As a former pharmacy manager, he remembers receiving alerts at the pharmacy where he worked. “It’s important for the pharmacies to help communicate [the message].”

With some 60,000 community pharmacies in the U.S., leveraging the pharmacies’ network can be “a powerful tool to get the information out,” he adds. However, some customers may never receive recall notices if they are not enrolled in the pharmacy’s communication system or have opted out of email or text alerts.

Even more worrying, according to Dr. Rudenberg, not all pharmacies have a standardized policy or infrastructure that allows them to reach out to patients on an individual basis.

“Unfortunately, a lot of the time, [the customers] find out from the media, and then they just don’t know what to do with that information, understandably,” she says. Inconsistent messaging from manufacturers, providers, and pharmacies could also leave patients confused about the implications of the recall and whether or not to continue taking the medication.

“When it comes to alerting the public, I would say that’s where the FDA falls short,” adds Dr. Rudenberg.

Further confusing the matter is the fact that the FDA does not issue a press release for every recall. Instead, it may post the company’s recall alert on its website and document recalls of FDA-regulated products on its Enforcement Report page.

While these websites are accessible to the public, they are “not something that the general public is aware of,” notes Dr. Rudenberg. “[People] take their medications, they put faith in what their healthcare providers tell them, and the onus isn’t really on them to seek out whether or not their drugs are safe and whether there are recalls or not.”

While she subscribes to MedWatch safety alerts, Dr. Rudenberg acknowledges that most healthcare providers don’t regularly monitor the site. Typically, it’s the hospital’s pharmacy procurement department that keeps tabs on such updates. “ [The healthcare providers’] job is to write a script and ensure that that script gets delivered to the patients. I don’t think they have the awareness, nor the time, to keep track of what is being recalled and whether the patients are on it,” she says.

Practical Steps for Handling a Recall

According to the FDA’s drug recall communication guidelines, a recall alert letter should include information on the product identity (brand name, dosage, lot, and NDC or UPC codes), the recall reason and the hazard involved, and what the recipient should do with the product (e.g., notify their customers, return or discard the the product). The letter will also include means for the recipient to report to the company any recalled products they have left.

“If the return or product disposal instructions are unclear, patients should talk with their pharmacist. If you are the pharmacist and the return instructions are unclear, contact the manufacturer or the FDA. If you are the prescriber, you may be asked to prescribe an alternative medication or write a new prescription to replace a returned product,” explains Dr. Elder in the podcast interview.

Most of the time, an alternative drug is available to replace the recalled product, says Dr. Alexander. “We’re fortunate that we have such a broad inventory when it comes to the FDA-approved drugs that are safe and effective, and available in the marketplace,” he says.

While the U.S. drug recall system is designed to protect patients, its layered bureaucracy and oversight gaps can leave critical warnings unseen. The best defense is to be proactive: build a rapport with your local pharmacist and sign up for the FDA’s MedWatch safety alerts so you’re notified at the first sign of trouble. Concerned consumers can also visit the FDA’s Office of Inspections and Investigations website, which offers contact information and useful tools concerning recalls.

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