Some were analyzed for impurities such as lead or whether their dosage levels matched the claims on their labels. Another test scrutinized the speed at which the tablets dissolved \u2014 a critical indicator of how medication is released in the body \u2014 and compared the results to the brand-name drugs.\u00a0<\/p>\n
While most of the samples passed, the findings showed that one version of bupropion and one version of metoprolol, dispensed at least tens of thousands of times in 2024 alone, had irregularities that experts say could compromise their effectiveness.<\/p>\n
![\"A](\"https:\/\/www.newsbeep.com\/ca\/wp-content\/uploads\/2025\/12\/20251219-fdatesting-web_DSC6546.jpg\")
As part of ProPublica\u2019s testing at the Connecticut-based lab Valisure, a scientist dropped samples of generic drugs into a solution to see how quickly they dissolved. Tonje Thielesen for ProPublica<\/p>\n
The tablets dissolved slower than their brand-name counterparts, which could leave patients without the right therapeutic levels for treatment and no way of knowing if their medication might be at fault.\u00a0<\/p>\n
Metoprolol is a beta blocker used by about 15 million people<\/a> for conditions like chest pain, heart failure and high blood pressure. Bupropion is a go-to drug for the treatment of depression, prescribed to about six million people in the U.S. each year.\u00a0<\/p>\n Oregon psychiatrist Dr. James Hancey said receiving incorrect amounts of bupropion throughout the day is a serious quality threat that puts vulnerable patients at risk.\u00a0<\/p>\n \u201cOne of the great potential dangers here is that people become discouraged and disillusioned,\u201d he said when told about ProPublica\u2019s findings.\u00a0<\/p>\n Hancey said he worries that patients taking ineffective antidepressants can feel hopeless, increasing suicide risk. \u201cSort of like, \u2018I must really be messed up. \u2026 I\u2019ll never get any better,\u2019\u201d he said. \u201cYou can only lose so much hope.\u201d\u00a0<\/p>\n Irregular levels of metoprolol can also pose a danger, especially for people with congestive heart failure or a history of heart attacks, said Dr. Art Kellermann, a longtime member of the National Academy of Medicine and former senior vice president for health sciences at Virginia Commonwealth University.<\/p>\n \u201cYou may never get to the level your body needs to be safe,\u201d he said.<\/p>\n Dozens of companies received approval from the FDA over the years to sell metoprolol and bupropion in the U.S. Yet from 2018 to 2024, the agency reported running only 2 tests on metoprolol and 7 on bupropion through its quality surveillance program \u2014 in each case, by pulling a sample from a single drugmaker. In many of those years, the drugs weren\u2019t tested at all, FDA records show. Those that were assessed received passing results.<\/p>\n The FDA did not respond to questions about why the agency didn\u2019t do more testing and how it can know that generics are safe without a more robust program. On its website, the FDA said it has relied on a \u201cmore targeted, risk-based\u201d approach<\/a> to testing since 2018, choosing samples of drugs that have safety, effectiveness or quality concerns. The agency publicly reports the results on its website and notes that a majority of the tested drugs meet its standards.<\/p>\n ProPublica, however, found the agency for years failed to routinely test not only the generics that have worried outside experts but also drugs coming from factories that amassed so many serious quality and safety violations they were ultimately banned from the U.S. market.<\/p>\n In 2023, the FDA barred two Intas Pharmaceuticals factories in India from shipping drugs to the U.S., in part because workers had manipulated drug-testing records to cover up bad results, government records show. An \u201cegregious pattern,\u201d regulators wrote in a letter to the company.<\/p>\n The agency simultaneously excluded the company\u2019s bupropion from that ban, a practice used by the FDA to avoid drug shortages<\/a>, and has only reported testing the medication once since then. It passed.\u00a0<\/p>\n ProPublica\u2019s testing, however, found the factory\u2019s bupropion dissolved more slowly than the brand-name drug as well as versions of the medication made by other generic manufacturers.<\/p>\n Intas, whose U.S. subsidiary is Accord Healthcare<\/a>, said in a statement that its bupropion is safe, effective and equivalent to the brand-name medication, and that the company has made improvements since the FDA\u2019s inspections, including bringing in third-party experts focused on quality and data integrity. The company added it is no longer manufacturing bupropion for the U.S.<\/p>\n In recent years, the FDA\u2019s own records show the agency has fielded thousands of complaints about generic versions of both bupropion and metoprolol. Some reports described seizures, cardiac arrest, nausea and other health problems. Others said the pills just didn\u2019t control patients\u2019 symptoms.<\/p>\n Kellermann and others said too many doctors shrug off those concerns, attributing them to bad luck or a patient\u2019s underlying conditions without considering that the medication itself could be the problem.<\/p>\n \u201cBefore we blame God or biology, what are we doing with the best intentions that might be hurting this patient?\u201d he said. \u201cIf we don\u2019t entertain the possibility that the patient is right, then we might overlook the true cause of their problem. That\u2019s why testing generic drugs to verify their quality and safety is so important.\u201d<\/p>\n \u201cAfraid of What It Could Find\u201d<\/p>\n Despite its reputation as one of the world\u2019s toughest drug regulators, the FDA takes a decidedly hands-off approach to testing. Its position hasn\u2019t wavered even though the drug supply chain is sprawling, with manufacturers scattered around the world. India produces about half of all generics used in the United States, and crucial ingredients are made in China.\u00a0<\/p>\n When manufacturers from those countries send drugs to the European Union, they are required to use labs on EU soil to test every batch before releasing them to the public. There is no such requirement in the U.S.<\/p>\n In interviews with ProPublica, former FDA officials and others who have studied the safety of generics said the agency should have done more years ago to probe the drug supply.\u00a0<\/p>\n Though billions of prescriptions for generic pills, tablets and vials of injectable medication are filled every year, the FDA reported conducting fewer than 650 tests under its quality surveillance program since 2018. That number includes many generic drugs, as well as some brand-name prescription drugs, over-the-counter medications like Children\u2019s Tylenol, and various drug ingredients.\u00a0<\/p>\n About 94% of those tests produced passing results, FDA data shows. In 2024, the most recent year with data, the agency reported the results of just over 50 tests.\u00a0<\/p>\n The total does not include tests on hand sanitizers and supplements or any other quality testing that is not publicly reported. The FDA sometimes commissions studies about drugs, which are also not reflected in the tally.<\/p>\n D\u2019Sa said the FDA\u2019s efforts aren\u2019t nearly enough.<\/p>\n As deputy director of the agency\u2019s India office in 2009, he said he worried that inspections alone couldn\u2019t guarantee Americans were receiving quality medication. His team was scouring facilities in every corner of the country and regularly reporting distressing results: factory after factory with no testing procedures to monitor the strength, quality or purity of drugs. Some factories weren\u2019t being inspected at all.\u00a0<\/p>\n In 2024, the FDA inspected a third<\/a> of India\u2019s nearly 600 manufacturing sites, agency data shows.\u00a0<\/p>\n \u201cRegular testing would be an objective measure of quality,\u201d D\u2019Sa said, noting that inspections only examine manufacturing practices at a single point in time.<\/p>\n Other agency insiders have also been concerned. One former official at the FDA\u2019s Center for Drug Evaluation and Research still remembers a phone call almost 20 years ago from a sobbing woman in Texas who said her husband had switched to a generic version of bupropion that she said wasn\u2019t effective. He killed himself.<\/p>\n \u201cThat used to keep me up at night,\u201d said the former official, who did not want to be identified because they still have ties to the agency. The FDA needed more training at its testing labs, among other improvements, the official said, but changes were slow.<\/p>\n In an interview, Janet Woodcock, the longtime head of drug safety at the FDA, said the agency didn\u2019t have the resources to do more testing and that she wasn\u2019t overly concerned about widespread lapses in quality.<\/p>\n \u201cA huge, huge majority of drugs on the U.S. market are totally fine,\u201d said Woodcock, who retired from the agency early last year.<\/p>\n Woodcock did not respond to a question about how she knows that drugs are safe if the FDA hasn\u2019t regularly tested them. Instead, she said, the best way to ensure quality is through training and improved manufacturing.<\/p>\n \u201cI don\u2019t believe random testing is an appropriate method for maintaining quality of the drug supply,\u201d she said.\u00a0<\/p>\n Some doctors and others said they believe the FDA decided against routine testing because it could undermine the public\u2019s confidence in generics and raise questions about the agency\u2019s oversight of the industry.\u00a0<\/p>\n \u201cThe FDA doesn\u2019t want to do the testing because it is afraid of what it could find,\u201d said pharmacologist Joe Graedon, who for years has advocated for drug safety reforms on his website The People\u2019s Pharmacy<\/a>.<\/p>\n The FDA has even resisted when groups outside the agency offered to help.<\/p>\n \u201cWe Want to Find the Really, Really Horrible Ones\u201d<\/p>\n Nearly every morning before dawn, a truck stocked with more than $2 million in prescription drugs arrives at the University of Kentucky\u2019s hospital. Without fail, chemist Robert Lodder\u2019s team of pharmacy technicians is there to greet it.\u00a0<\/p>\n While other hospital employees ready the sterile injectables for use, Lodder\u2019s technicians siphon off samples and whisk them off to a small lab tucked inside the pharmacy. There, they put the samples on a machine called a spectrophotometer to get a picture of each drug\u2019s chemical composition.\u00a0<\/p>\n If the medication is made properly, Lodder and his team would see a similar image for every batch. Too often, something doesn\u2019t look right.<\/p>\n Lodder has screened hundreds of thousands of samples since 2020, representing about 350 different medications. About 10% of those drugs have failed the initial assessment and were removed from the hospital\u2019s supply for further study. Some were cleared after Lodder looked at them a second time, but he was so concerned about 20 different drugs that he reported the problem to the FDA and urged the hospital to change suppliers if it could.<\/p>\n Lodder first became interested in drug quality when he was a graduate student at Indiana University in the 1980s. At the time, people were dying after someone tampered with over-the-counter pain relievers to lace them with cyanide, prompting Lodder to study the makeup of similar drugs. When he took the job at the University of Kentucky in 1988, he urged his bosses to set up a lab to screen medications.<\/p>\n Lodder knew the FDA assessed \u2014 and nearly always passed \u2014 samples from only a small number of drugs. For sterile injectable medication, which can be particularly dangerous if contaminated, Lodder wanted to look at every vial that came through the hospital\u2019s doors.<\/p>\n \u201cWe want to find the really, really horrible ones,\u201d he said. \u201cThere\u2019s almost always \u2026 a few that you would not want to put out there.\u201d<\/p>\n In 2023, Lodder traveled to Washington, D.C., to talk about his screening program with officials from the FDA and the White House Office of Science and Technology Policy. He had given the group a data file identifying the drugs that failed his initial screening, including chemotherapy drugs to treat leukemia and breast cancer. Lodder expected the FDA to dig into his findings.\u00a0<\/p>\n But agency officials, he said, asked only a few questions.<\/p>\n \u201cThey weren\u2019t listening to us,\u201d he said. \u201cPeople were indifferent, like, \u2018Is this really necessary?\u2019\u201d<\/p>\n The way to ensure drug quality, Lodder recalled pitching the group, is to launch a large-scale testing program and publicize the results, which would force troubled manufacturers to make improvements. He suggested that academic medical centers could do the work: screening medications, pooling their data and reporting results to the FDA and to the public.<\/p>\n His own testing program cost less than 0.01% of the hospital pharmacy\u2019s drug budget.<\/p>\n \u201cThen the public will know who has the best,\u201d he said. \u201cThat\u2019s what we want out of all of this: You know who to buy from. You can judge on quality as well as price.\u201d<\/p>\n The FDA did not respond to ProPublica\u2019s questions about Lodder\u2019s proposal.<\/p>\n He went back to Kentucky after that 2023 meeting, convinced little change would come from Washington. Lodder didn\u2019t know the details at the time, but another arm of the U.S. government was just as concerned about the nation\u2019s drug supply as he was.<\/p>\n A Matter of National Security<\/p>\n As a global supply chain commander in the Army, Col. Vic Suarez didn\u2019t rattle easily. But he kept hearing something that, if true, could put soldiers at risk: The military\u2019s doctors were worried that some of the generic drugs they were prescribing, particularly from India and China, weren\u2019t working as they should.\u00a0<\/p>\n In 2019, Suarez recalled that at least one doctor was specifically troubled by tacrolimus, an immunosuppressant medication used by organ transplant patients to prevent rejection. Some generic versions didn\u2019t appear to deliver the right dose<\/a>, risking the lives of fragile patients. Suarez started advocating for additional drug-quality testing and took the idea to top leaders.<\/p>\n In 2023, the Defense Department decided to investigate generic medications commonly used by U.S. service members and veterans.\u00a0<\/p>\n \u201cWe saw it as our responsibility to protect our own service members and their families,\u201d Suarez said.<\/p>\n Suarez hoped to explore a collaboration with the FDA, an effort previously reported by Bloomberg<\/a>. In June of that year, he and a group of officers met with the leaders of the Center for Drug Evaluation and Research.<\/p>\n At the meeting, which has not been previously reported, FDA officials pushed back on the plan. They questioned the kind of testing the Defense Department was planning and the independent lab that would do it, according to a transcript obtained by ProPublica. One said the Defense Department\u2019s concerns about drug quality could damage public trust and \u201cundermine confidence in the drug supply.\u201d<\/p>\n After the meeting, the agency summarized the discussion in a confidential memo, noting that a majority of drugs tested by the agency over the years had met quality standards. The memo pointed to a 2020 FDA study<\/a> that tested more than 250 so-called \u201cdifficult-to-make prescription\u201d drugs and didn\u2019t surface any problems.<\/p>\n \u201cAs the agency with jurisdiction over the pharmaceutical industry due to our extensive experience with manufacturing and testing \u2026 FDA has substantial concerns about the proposed pilot,\u201d the agency said in the unsigned memo, which was obtained by ProPublica.<\/p>\n The FDA did not respond to questions about the Defense Department\u2019s initiative or the meeting.<\/p>\n The DOD is using the independent lab Valisure to test more than 40 drugs that officials consider the most essential in the military health system, representing roughly 2,000 versions of the medications. The vast majority are generic. Early results show about 10-15% of those drugs are high risk, meaning they were found with elevated levels of contaminants, didn\u2019t have the right dosage or dissolved differently than higher-quality generic or brand versions.<\/p>\n \u201cUltimately, the people that are disproportionately affected are the most vulnerable,\u201d Suarez said. \u201cThere is no other protection for them other than people trying to do the right thing \u2026 to literally fill the gap by basically testing and comparing.\u201d<\/p>\n ProPublica also engaged Valisure to conduct drug testing. As part of that testing, the lab earlier this year tested generic tacrolimus made by Intas<\/a> and found that the capsules dissolved up to three times faster than the name brand, which experts say could introduce too much of the drug too quickly and potentially cause tremors, headaches and kidney failure.<\/p>\n The FDA in 2023 said Intas\u2019 tacrolimus may not provide the same therapeutic effect<\/a> as the brand name but that the drug could still be prescribed.<\/p>\n In a previous statement, Intas said its tacrolimus is safe and effective and that the FDA had determined the drug was equivalent to the brand-name version when it was first approved for the U.S. market. The company said it \u201cis dedicated to patient safety, product quality, and regulatory compliance.\u201d\u00a0<\/p>\n \u201cYou Don\u2019t Want a Bad Batch\u201d<\/p>\n Long before ProPublica launched its own testing, Graedon, the drug safety advocate at The People\u2019s Pharmacy, asked another testing provider to assess a generic version of bupropion by Teva Pharmaceuticals, which is headquartered in Israel.<\/p>\n That testing showed the pills were dissolving more rapidly than branded ones<\/a>. Patients with depression who had once found relief in Wellbutrin had described headaches, anxiety and, in some cases, suicidal thoughts. In 2007, Graedon urged the FDA to investigate, even sending dozens of pill bottles to agency headquarters in Maryland.<\/p>\n In 2012, after sponsoring its own study, the FDA announced<\/a> that Teva\u2019s version, which was made by Impax Laboratories, was not equivalent to the brand and Teva removed it from the U.S. market.<\/p>\n Teva did not respond to requests for comment. At the time, the company said the medication posed no safety concerns<\/a>. In 2017, Impax announced<\/a> it was merging with another company.<\/p>\n Since then, the FDA has only sporadically tested generic versions of bupropion, government data shows, even when drug companies appeared to have manufacturing issues.<\/p>\n India\u2019s Sun Pharma has recalled its bupropion at least six times since 2016 because it wasn\u2019t dissolving correctly, government records show. FDA inspectors have gone back to the Sun factory that made the drug time and again, reporting dirty equipment, fungus in areas that were supposed to be sterile<\/a>, and bacteria and metal particles in injectable medication.\u00a0<\/p>\n![\"A](\"https:\/\/www.newsbeep.com\/ca\/wp-content\/uploads\/2025\/12\/20251219-fdatesting-web_DSC5816.jpg\")
A scientist preps samples of the antidepressant bupropion XL for ProPublica\u2019s testing. Tonje Thielesen for ProPublica<\/p>\n![\"Three](\"https:\/\/www.newsbeep.com\/ca\/wp-content\/uploads\/2025\/12\/20251219-fdatesting-web_DSC6493.jpg\")
Though generic drugs have poured in from overseas factories, the FDA opted to conduct only sporadic testing for quality. Tonje Thielesen for ProPublica<\/p>\n![\"A](\"https:\/\/www.newsbeep.com\/ca\/wp-content\/uploads\/2025\/12\/20251219-fdatesting-web_DSC6371.jpg\")
Valisure tested drugs for impurities, such as lead and arsenic. Tonje Thielesen for ProPublica<\/p>\n![\"A](\"https:\/\/www.newsbeep.com\/ca\/wp-content\/uploads\/2025\/12\/20251219-fdatesting-web_DSC6026.jpg\")
At Valisure, tablets were crushed in advance of testing for heavy metals. Tonje Thielesen for ProPublica<\/p>\n![\"A](\"https:\/\/www.newsbeep.com\/ca\/wp-content\/uploads\/2025\/12\/20251219-fdatesting-web_DSC6257.jpg\")
Valisure\u2019s lab tests for heavy metals. Tonje Thielesen for ProPublica<\/p>\n![\"A](\"https:\/\/www.newsbeep.com\/ca\/wp-content\/uploads\/2025\/12\/20251219-fdatesting-web_DSC6116.jpg\")
The Department of Defense is also using Valisure to test generic drugs. \u201cWe saw it as our responsibility,\u201d said Col. Vic Suarez. Tonje Thielesen for ProPublica<\/p>\n![\"A](\"https:\/\/www.newsbeep.com\/ca\/wp-content\/uploads\/2025\/12\/20251219-fdatesting-web_DSC6099-copy.jpg\")
Valisure is testing more than 40 drugs that officials consider the most essential in the military health system. Tonje Thielesen for ProPublica<\/p>\n
![\"A](\"https:\/\/www.newsbeep.com\/ca\/wp-content\/uploads\/2025\/12\/20251219-fdatesting-web_DSC5642.jpg\")
The testing at Valisure ultimately found that one version of the antidepressant bupropion and one version of the heart medication metoprolol dissolved more slowly than their brand-name counterparts, which could leave patients without the right therapeutic levels for treatment. Tonje Thielesen for ProPublica<\/p>\n