Generic Drug Failures: When Cheap Drugs Turn Costly

ly disappointingWhen the world’s most prestigious medical journal publishes a paper titled “Substandard Generic Drugs – Threats to Patient Safety and National Security (New England Journal of Medicine, March 18, 2026),” you would think that medical organizations worldwide would stop and pay close attention to a warning about generic drug failures. In particular, you would hope that the FDA, the HHS, the NIH, the AMA [American Medical Association], all pharmacy organizations and all healthcare workers would sound an alarm. You would be wrong.

As far as I can tell, there has been no response from the Food and Drug Administration, even though I have tried to be polite in my inquiries. The FDA is responsible for approving and monitoring generic drug quality. I have seen nothing from HHS (Health and Human Services), which oversees the FDA’s activities.

More shocking than a lack of government response is the seeming silence from clinicians: physicians, pharmacists, nurses and their various associations. These are the people who prescribe, dispense and administer generic medications. Why aren’t they up in arms? If some of the medicines they rely upon to help patients are potentially “substandard,” is that not a national crisis?

Equally alarming has been the absence of a reaction from organizations that are supposed to support patients: The American Association of Retired Persons (AARP), the National Consumers League (NCL), the Consumer Federation of American (CFA) and Consumer Reports (CR). Where is the outrage?

Do Generic Drug Problems Worry You?

Do you take any medications? Nearly half of all Americans take prescription drugs (Demography, Oct. 1, 2023).  Make that 85 percent of seniors (NCHS Data Brief, May 2019). Such medicines are a key component of health care.

The vast majority of these prescriptions–more than 90 percent–are filled with generic drugs. The Food and Drug Administration (FDA) maintains, as it has consistently, that “FDA-approved generic drugs have the same high quality, strength, purity and stability as brand-name drugs.”

The New England Journal of Medicine (NEJM) Perspective

The authors (Kevin Schulman, MD, of the Stanford University School of Medicine and Arthur L. Kellermann, MD, MPH, of the Emory University School of Medicine) of the article in the NEJM seemingly disagree with the FDA.

These physicians point out that generic drugs now represent “more than 90% of the prescriptions filled in the United States.” They go on to report structural problems with the generic drug supply chain:

• Manufacturing has moved offshore. The overwhelming majority of generic medications are now produced outside the United States, driven by the relentless pressure to cut costs. Many foreign manufacturing facilities operate in countries with lax regulatory controls.

• The FDA cannot keep up with inspections. The authors note that in 2022, the Government Accountability Office reported that 61% of foreign drug manufacturing plants had not been inspected by the FDA in the preceding five years. That is not a gap. It is a chasm.

• When inspections do occur, problems are found. Quality control documents are occasionally altered or destroyed. Drug ingredients may be stored in questionable conditions. High concentrations of nitrosamines — cancer-causing chemicals — have been detected in several commonly prescribed generic medications made abroad.

• The FDA’s de facto posture seems to be: “no harm, no foul.” But as we will show you through the stories of real patients, people have been harmed.

How Could the FDA Allow Generic Drug Failures?

When I started writing about pharmaceuticals 50+ years ago, I was one of the country’s most ardent supporters of generic drugs. At that time, brand name medications dominated the marketplace, but I was convinced that people could save a lot of money by requesting generics whenever possible. I even debated a Big Pharma representative on Good Morning America.

In those days I completely trusted the Food and Drug Administration to guarantee generic drug quality. Over the intervening decades, though, I have heard about far too many generic drug failures. I believe the FDA has let us down. In some cases, poor-quality generic drugs could lead to a return of symptoms. In other cases, they could be be life threatening.

Physicians and Pharmacists Should Believe Patients!

This visitor to our website wrote:

“My husband was hospitalized for acute kidney transplant rejection. In the hospital, the doctor was very concerned to learn that he had switched a few months earlier to the generic form of tacrolimus. Before that, he had been on Prograf for years with no rejection problems.

“The doctor said that they had at least two other patients who were treated for rejection after switching to the generic. We couldn’t believe it, since he asked the nephrologist if it was OK before he switched.

“Unfortunately, my husband’s transplant couldn’t be saved. He is currently back on dialysis waiting for another kidney transplant.”

Anti-rejection drugs are a particular concern to us. That’s because there is little room for error. Too little and the transplanted organ can fail. If this idea worries you, please listen to our radio show/podcast interview with Loretta Boesing, founder of Unite for Safe Medications.

Show 1351: Are You Risking Your Life Trusting Mail Order Medicines?
A mother whose child relies on medicine to prevent transplant rejection found that his medicines lose potency during shipping.

Other Reports of Generic Drug Failures

We have heard from a great many people who have had trouble with generic antidepressants.

Here is just one person’s story:

“When my insurance took Wellbutrin off their formulary list, my co-pay went through the roof. I began taking generic buproprion. Soon I experienced severe depression. My doctor now writes my prescriptions as NBO (‘name brand only’).”

This reader shared an unpleasant experience with us in June, 2025:

Q. I was prescribed pantoprazole for GERD problems. When I took the first dose, it was like a miracle – my reflux symptoms disappeared overnight.

The relief continued until I refilled the prescription. On the new refill, my daily symptoms resumed immediately. My doctor couldn’t explain why my heartburn returned.

It then occurred to me that my problems started right after the refill. I spoke to my pharmacy and received a new 30-day supply. After taking the first dose, my symptoms again disappeared completely.

The pharmacy said they had no way to verify whether the pills from the previous refill were defective. I filed a complaint with the FDA on Form 3500 reporting the lack of efficacy with the drug I received. A few days later the drug manufacturer sent me a questionnaire.

It bothers me that the FDA is asking the drug company to investigate itself. It also bothers me that my pharmacist did not know to direct me to FDA Form 3500. Apparently, no one is really looking out for the millions of generic drugs being administered.

A. We have been alarmed about the FDA’s lax oversight of generic drug quality for many years. Investigative reports from ProPublica and Bloomberg have revealed a shocking lack of federal concern about quality. We are also disturbed that many pharmacists and physicians have seemingly ignored this problem.

To learn more about this serious situation, you may want to read our book, Top Screwups. It provides practical information for patients and encourages health professionals to take this crisis seriously. You can find Top Screwups in the book section of the store. Consider giving a copy to your doctor or pharmacist.

When Are Generic Drug Failures Dangerous?

The Food and Drug Administration states that:

“Currently 90 percent—9 out of 10—of all prescriptions dispensed in the United States are for generic drugs.”

The agency maintains that all FDA-approved generic products are “…safe, effective, high-quality drugs…” We are not so sure. More about that in a moment.

For many generic drugs, it may not matter if they are a perfect match for the brand name. I do not worry very much about generic diazepam (Valium), for example. A little more or a little less of the active ingredient is rarely an emergency. Ditto for the pain reliever celecoxib (Celebrex).

We have heard from quite a few people that generic celecoxib does not always work as well as the brand name. You can read their stories at this link. At last count, over 300 people have commented about this problem, but for most of them it is not a life-threatening situation. Many complain that their arthritis pain comes back, but they are still functional.

We view generic drug failures as critical when it comes to antibiotics like doxycycline for Lyme disease or Rocky Mountain Spotted Fever. If the generic drug does not work, it could indeed be life threatening. The same could be said for medications that are prescribed to prevent organ rejection. If someone gets bad tacrolimus, they could lose their new kidney and ultimately their life.

Generic Drug Failures and Epilepsy

I consider epilepsy a condition that requires perfect quality. This parent describes a worrisome outcome associated with generic Keppra:

Q. My 7-year-old child had not had a seizure in four years. Her epilepsy has been controlled with Keppra and the ketogenic diet.

Recently, she was switched to levetiracetam, the generic form of Keppra, and now the seizures have returned.

I am so disappointed and worried. How can I get the pharmacy to dispense name brand Keppra?

A. Many others have complained on our website that generic versions of Keppra were less effective than the brand name. Here is a link to an article I wrote a few years ago:

Generic Drug Recall Linked to Deaths

One person with epilepsy was well controlled for years on Keppra. After being switched to the generic form she had several seizures within two weeks. She noted, “this was life threatening since I fell down stairs and also had a seizure while cooking.” After her doctor insisted on Keppra, her seizures were once again controlled.

We brought this issue to the attention of the FDA over 15 years ago. Officials told us they were investigating, but it could take some time. As far as we can tell, the agency has never responded further.

We are not the only ones to complain about generic levetiracetam.

An article in the Annals of Pharmacotherapy (May, 2011) reported similar problems:

“Patients reported an increase in seizure activity to their neurologists after treatment was switched from Keppra to generic levetiracetam formulations. To confirm the timeline of increased seizure activity with use of the generic drug and report these adverse events to MedWatch, we made a telephone call to each patient’s pharmacy to collect information on dispensing dates and the generic formulations’ manufacturers. Subsequent to the increase in seizure frequency with generic levetiracetam, treatment in all 4 patients was switched back to Keppra. Seizure frequency in all patients returned to baseline when Keppra was reinstituted.”

Generic Drug Failures Are Still Happening

If you were alert you noticed that the date on the article above was 2011. We received a tremendous number of similar complaints around the same time. That is because before levetiracetam became available, most patients had to take the brand name Keppra. They could tell the difference quite quickly.

These days, most people with epilepsy do not have the “luxury” of starting treatment with brand name Keppra. Therefore, they have no way to compare brand name to generic.

Avoiding Life-Threatening Generic Drug Failures

Here is a message about avoiding generic levetiracetam by purchasing brand name Keppra from Canada:

Q. My doctor prescribed Keppra and Tegretol for my epilepsy. I do not want to take the generic forms, so I buy the brand name products from a Canadian pharmacy. Three months of Keppra is about $900 there and Tegretol about $200.

In the US, they would be $4,176.00 and $1,567.00 for three months respectively, so I save about $4,600 over that time.

I have had no problems with the Canadian pharmacy, and they usually source these brand name drugs from the UK. I do have to plan ahead, though, to allow for shipping time. I thought others could benefit from my experience.

A. We have heard from many readers that switching from brand name Keppra to the generic anticonvulsant levetiracetam may lead to breakthrough seizures, so we understand why you have chosen to stick with the brand name.

Because the brand-name medicine is so expensive in the US, a more affordable Canadian pharmacy makes sense. Not all online pharmacies that claim to be Canadian actually are legitimate, though. To verify, look for the provincial pharmacy license number on the website. There also must be a physical address in Canada. A certification seal from CIPA (Canadian International Pharmacy Association) is also reassuring.

We summarize this and much more information about ordering from legitimate Canadian pharmacies in our eGuide to Saving Money on Medicines. This online resource can be found under the Health eGuides tab on this website.

Recommendations from The Authors of the

Drs. Schulman and Kellermann offer these suggestions to improve generic drug safety:

1. Acknowledge that a problem exists. Since the FDA does not test drugs itself, it cannot claim with confidence that all approved generic drugs meet quality standards. This pretense must end.
2. Empower accredited third-party laboratories to test generic drugs and use those results to prioritize FDA inspections.
3. Publish quality scores publicly. With transparent testing data, both patients and government purchasing programs could choose higher-quality generic medications rather than defaulting to the lowest bid.
4. Create incentives to bring drug manufacturing back to the United States. Supply chain resilience is not just a patient safety issue — it is a national security issue.

These are sensible, achievable reforms. The question is whether anyone with power will act. What do you think?

Share Your Story

Have you had good luck with generic drugs? If so, please provide the details in the comment section below. Have you had problems with generic drugs? We would like to read your story as well. People who comment can remain anonymous, so no worries in that regard. If you have had success with an online Canadian pharmacy, we would also like to read about your experience.

If you could share this story with friends or family we would be grateful. We have been warning about generic drug failures for decades. It is extremely disappointing hat very few professional organizations have been paying attention. We are even more saddened that consumer organizations such as Consumer Reports and AARP seem so oblivious and uncaring. If you belong to any professional or consumer groups, please alert them to this article. Perhaps you could also share it with your healthcare providers. Thank you for supporting our work.