News Coverage
The Partnership for Safe Medicines has been publishing information about the counterfeit drug problem around the world for more than a decade. With experts leading the organization and a committed and passionate set of writers and editors, our content is more in-depth than many other sources, which simply copy links to the news from other websites.
Pill presses and molds are used to make fake pills with deadly consequences thousands of people every year. The number of Americans that take fake pills annually without a fatal event is even higher. Read our January through June 2025 report covering pill press seizures, policy developments, and legislation.
Avanish Kumar Jha and Rajnish Kumar Jha got 30-month sentences for selling counterfeit medicines—including vials of fake Keytruda—to U.S. buyers.
After a November 2024 inspection, the FDA issued a Form 483 to Empower Clinic Services highlighting violations related to compounded drug manufacturing practices at its East Windsor, New Jersey facility.
The change will affect the Google Ads and Google Shopping platforms starting in September 2025.
A July 1, 2025 post clarifies that applicants can use “a static baseline approach for the cost-savings analysis” instead of trying to account for changes in unpredictable markets.
The operation launched 1,728 investigations in 91 countries and shut down 13,000 criminal-linked websites, social media pages, channels, and bots used to market and sell illegal or counterfeit medicines.
On June 26, PSM commented in support proposed revisions to forms FDA 3500 and FDA 3500B, which are used to report adverse events from prescription and over-the-counter medicines.
More than 40 cases of botulism linked to Botox injections have been reported in the U.S. and U.K. over the last two months.
The bill permanently schedules fentanyl analogues as Schedule I drugs under the Controlled Substances Act.
The Jha brothers admitted selling counterfeit Keytruda and other prescription drugs to undercover agents.
PSM is soliciting feedback on draft best practices until June 20th. Please review the guidelines and send your thoughts to editors@safemedicines.org.
The FDA warned companies over the sale of an unapproved medical device and contaminated eye medicines, and disbarred a Texan who sold illegally imported pharmaceuticals.
The FDA has announced a voluntary nationwide recall of two dietary supplements sold exclusively online by www.umary-usa.com. Lab testing revealed that Unavy Ácido HIALURÓNICO and Umovy Ácido HIALURÓNICO contain undeclared active pharmaceutical ingredients: diclofenac, dexamethasone, and omeprazole.
Federally-registered compounding facilities stopped making tirzepatide on May 22. This transition is significant for patients, and we at PSM think there are four things you should be watching for.
Operation RapTor led to 270 arrests and the seizure of more than $200 million in currency and digital assets.
Articles in Endpoints News and the Houston Chronicle raise questions about the regulatory process for 503B compounding facilities.
Exposes in the Houston Chronicle and Endpoints News examined Empower Pharmacy’s safety record. A grand jury indicted a Chinese company and three of its employees for pill press and counterfeit die mold sales.
The FDA wants to ensure that domestic and foreign companies receive the same level of regulatory oversight.
Catch up on research PSM released about medicines imported from unregistered sources.
What if your blood thinners were made in an unverified location in Colombia? In March 2025, dozens of pharmaceutical shipments entered the U.S. that were manufactured in places no one would expect.
New research shows a correlation between compounded weight loss and diabetes injectables and increased adverse events. GIlead Sciences is suing another New York City pharmacy that allegedly sold counterfeit HIV medicine.
The FDA has issued a warning to the operators of the online pharmacy www.thesafepills.org for illegally selling unapproved and misbranded opioid medications, including tapentadol products marketed as Aspadol and Typendol. These unauthorized drugs, sold without a prescription, pose significant health risks such as overdose, addiction, and even death.
One of SafeChain’s three owners pleaded guilty. The company collected secondhand HIV medicines from patients and resold them to licensed U.S. pharmacies, forging paperwork to make them look legitimate.
A Kentucky doctor treated weight loss patients with research chemicals; CBP seized 90,000 alprazolam pills being smuggled into the U.S.
The FDA and Novo Nordisk are warning the public about counterfeit Ozempic injections circulating in the U.S. drug supply chain. The falsified products, labeled with lot number PAR0362 and serial numbers beginning with 51746517, were seized by the FDA on April 9, 2025. Their contents and safety are unverified and pose serious health risks.
PSM is seeking input on developing a set of best practices to reduce sales of counterfeit and diverted medicines on online pharmacy-to-pharmacy marketplaces.
The FDA announced that it had seized counterfeit Ozempic injections on April 9. PSM testified at a congressional hearing.
A study examined the 130 enforcement actions undertaken by the U.S. Food and Drug Administration’s Office of Criminal Investigations from 2016 through 2021.
The state of Colorado submitted a revised application to the U.S. Food and Drug Administration to operation a Canadian drug importation plan in March. This blog post examines how the state’s application has changed over the years.
A March 12, 2025 memo said the state had paid more than $150,000 defending itself in a lawsuit Amgen had filed over plans to set an upper payment limit on its rheumatoid arthritis treatment, Enbrel.
Senator Jim Banks asked pointed questions about how FDA will stem the tide of semaglutide and tirzepatide coming from unknown facilities.
“Alternative funding programs” are shifting expensive prescription coverage to illegal drug importation schemes.
On March 14, the Partnership for Safe Medicines submitted comment on Customs and Border Protection’s proposed update to regulations around low-value, “de minimus” shipments.
A Texas man billed government programs millions for creams compounded by untrained teenagers. News about counterfeit medicine in six U.S. states.
FDA’s shutdown of GLP-1 compounding could lead to a new era of risk for U.S. patients.
The FDA published an update to a previous alert about undeclared active pharmaceutical ingredients in a dietary supplement to expand the package styles affected by this warning.
An FDA alert shared information on a nationwide recall of a nasal wash system due to microbrial contamination.
An FDA alert warned that Central Admixture Pharmacy Services issued a nationwide recall of Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bag due to the detection of black particulate matter in a single sealed vial of Phenylephrine Hydrochloride.
An FDA alert warned that Vitafer-L has been found to contain undeclared tadalafil, an active pharmaceutical ingredient. Products containing tadalafil cannot be marketed as dietary supplements.
The U.S. Attorney’s Office in the Western District of Washington has charged two Indian nationals with selling Americans counterfeit Keytruda.
There has been controversy about the ad Hims & Hers ran during the Super Bowl. And now an SEC filing says investors should be warned about risk if their ads are found to be non-compliant.
This is a reprint of an FDA Alert.
PSM’s new report shows that unregulated semaglutide and tirzepatide are slipping by FDA and CBP at the border. Semaglutide is no longer in shortage.
The Partnership for Safe Medicines today released a new report that found suspicious, unauthorized, and illegal ingredients for popular diabetes and obesity injectables (commonly known as weight loss drugs) are flooding into the U.S. from foreign sources despite U.S. laws forbidding them from coming through the border.
The Partnership for Safe Medicines applauds the Arkansas State Board of Pharmacy for utilizing new product verification technology for identifying illegitimate Ozempic quarantined by a pharmacy this week.
Mystery cosmetic injections allegedly harmed a client in Queens. PSM addressed a misleading drug ad for compounded weight loss medicine.
You could tell an American that they’re getting a compounded medicine and they would have no idea what that meant. That may be a legal disclosure, but that’s not good enough to protect patients who don’t know what the words mean.
PSM sent the following letter to the FDA’s Office of Prescription Drug Promotion (CDER) asking them to enforce the laws and guidelines that protect Americans from misleading advertising in the Hims&Hers Super Bowl ad.
PSM sent the attached letter to Fox Broadcasting, calling on them to withdraw the deeply troubling and misleading Hims&Hers Super Bowl ad.
Employees of the now-closed Chinese chemical company Hubei Amarvel Biotech were convicted at trial after shipping more than 200 kilograms of fentanyl precursor chemicals to the U.S. between November 2022 and June 2023.
Partnership for Safe Medicines released the following statement in response to the advertisement that lifestyle brand Hims & Hers released ahead of the Super Bowl to sell unregulated compounded weight loss drugs
Last week a Canadian man got 30 years for selling Americans counterfeit Xanax on the dark web and a New York spa owner was arrested after he allegedly injected patients with fake Botox
A new FTC report examines how PBM business practices have inflated drug costs.
Information provided to WHO by AstraZeneca, the genuine manufacturer of IMFINZI, has confirmed that the products identified in this Alert are falsified. Laboratory analysis of samples of the falsified IMFINZI have been carried out by AstraZeneca. The analysis confirmed that the vials of the falsified product contained no active pharmaceutical ingredient.
WHO reported a fake cancer treatment. This year’s Notorious Markets report focused on fake online pharmacies. Board member Andrea Thomas urged fraternities to stock Narcan.
As prescription medications containing fentanyl and other illegal substances are becoming more widely accessible worldwide, a global crackdown on illicit drug precursors is leading cartels to experiment with the contents of their products.
FDA analysis has found these products to contain undeclared Furosemide, Dexamethasone and Chlorpheniramine. Furosemide was found at 5.24 mg/g or 1.84 mg/capsule. Dexamethasone was found at 2.22 mg/g or 0.780 mg/capsule. Chlorpheniramine was found at 4.38 mg/g or 1.54 mg/capsule.
Two new cases involving black market medicine in Texas and Tennessee, and CPB seized thousands of pills in Laredo.
The lawsuit against Snap may proceed and the ADA issued a statement about compounded GLP-1 medicines.
A California man must pay millions in restitution for selling fake HIV meds. Additional news about Virginia’s state drug importation plans, prosecutions around fentanyl pills, and overseas incidents.
A California man allegedly processed payments for foreign online pharmacies selling fentanyl and meth pills.
Novo Nordisk filed five more lawsuits against businesses selling compounded semaglutide. Dr. Tim Mackey spoke about the dangers of the unregulated semaglutide sales online, and South Africa warned residents about counterfeit Ozempic.
Consumption of products with undeclared sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population, who are most likely to use this product, adult males who use nitrates for cardiac conditions are most at risk.
Use of products with undeclared diclofenac may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines. This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products.
Another China-based chemical company was indicted for allegedly selling precursor chemicals and xylazine to U.S. buyers as Americans continue to grapple with the toll of counterfeit prescription pills made with dangerous drugs.
On August 14, 2024, FDA received a complaint from a patient who noticed a black particulate in a vial of semaglutide distributed by Fullerton Wellness. On September 23, 2024, FDA received information from California regulatory authorities as part of ongoing collaboration between FDA and the state noting deficiencies found at Fullerton Wellness during a state inspection. After the state inspection, Fullerton Wellness voluntarily ceased operations.
The agency urges manufacturers, including repackagers, to clearly identify any ingredients intended for use in foods or dietary supplements on the label. Providing this information on ingredient labels could help prevent compounders from using ingredients that are not appropriate for sterile drugs and may help prevent patient harm.
This week the agency warned about compounding safety and sterility issues and a newly posted document shows inspectors enforcing manufacturing standards.
Chinese companies and individuals indicted by the Department of Justice and a study examines how patients were harmed by the sudden removal of a medication from a drug formulary.
The FDA recently announced that “connected trading partners” that have made progress in transmitting electronic data that identifies and follow medicines made for the U.S. drug supply will not be penalized if they are still working out challenges in the process. Are you wondering what that means? We can explain.
Family advocates petition the Office of U.S. Trade Representative to take trade action over Chinese fentanyl precursors. The New York Times tackles PBMs and pharmacy deserts.
Consumers taking this product should immediately consult with their health care professional to safely discontinue use of this product. The risks of withdrawal from corticosteroids should be assessed by a healthcare professional. Only licensed health care professionals can evaluate patients for the risk, or confirm the existence, of adrenal suppression. Consumers that have product which is being recalled should return to place of purchase or discard.
The FDA granted exemptions for certain trading partners and small dispensers to avoid supply chain disruptions. Stories from the week in counterfeit medicine news.
Our Executive Director, Shabbir Safdar, along with PSM members, shared examples of pharmaceutical counterfeits and helped attendees understand why current systems for stopping counterfeit product sales do not work well.
An indictment by the Department of Justice against 18 individuals who allegedly sold counterfeit pills via dozens of fake pharmacy websites to residents in all 50 states prompts warnings from two additional federal agencies.
Twenty-seven people in Puerto Rico indicted in misbranded and diverted drug case, CBP seized counterfeit and misbranded drugs in two states, and fake arthritis and cancer medications seized in India.
PSM commissioned a survey about compounded diabetes and weight loss injectable drugs. 1,000 likely voters across political affiliations were crystal clear — they are worried about safety and the current lack of oversight. See the full results.
The Federal Trade Commission issued an administrative complaint against the three largest pharmacy benefit managers, alleging that the companies used their market power to inflate the cost of insulin for U.S. patients.
If used chronically at the recommended dose, dexamethasone could cause severe and serious adverse events such as adrenal suppression (a disorder in which the adrenal glands do not produce enough hormones), central nervous system and psychiatric/behavioral effects, weight gain, gastrointestinal effects, elevated blood glucose, increased infection risks, neuromuscular and skeletal side effects, ocular effects, cardiovascular effects, dermatologic effects endocrine and metabolic issues, among other adverse events not mentioned.
Rxeed’s suit of CVS Caremark alleges predatory practices against independent pharmacies. Walgreens joins up with NABP’s Pulse. Stories about medicine safety in the U.S. and around the world.
Reuters writes about fake Ozempic and medicine tracking. The U.S. FDA issues warnings about supplements that contain undeclared prescription medicine. Additional news in India and Nigeria.
Guilty pleas in two federal cases involving dangerous medicines. Pill press news in South Carolina. Additional news in the U.K., India and Pakistan.
Researchers have found pentobarbital in counterfeit prescription pills. Plus, domestic and international news, and what our executive director is reading this week.
This is a reprint of an FDA Alert. Boulla LLC Issues Voluntary Nationwide Recall of Boom Max Capsules Due to the Potential Presence of Undeclared Sildenafil When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company’s announcement as a public service. FDA does not endorse either the product or…
A whistleblower complaint alleges that counterfeit and misbranded diabetes medical devices were being sold by third-party vendor on Amazon and orders were fulfilled by Amazon.com itself.
A new lawsuit says that another ring has been selling counterfeit HIV medicine in the U.S. Eli Lilly is taking action against compounders selling tirzepatide. More domestic and international news.
A New York couple admitted to selling sildenafil in supplements they claimed were “all-natural.” Ethiopian researchers say that one-fifth of medicines in African are fake or substandard. Additional news in Canada, the U.K, Thailand and Kurdistan.
A white paper examines how to detect and respond to substandard and fake medicine. A small study shows why buying semaglutide on line is dangerous. Police in Ukraine busted a counterfeit medicine drug ring. These stories and more in this week’s news.
A study published Friday in the Journal of the American Medical Association (JAMA) underscores the urgency.
The FDA warns that patients are harming themselves using compounded semaglutide. Cases involving pill presses in two U.S. states and two other countries.
FDA has received reports of adverse events, some requiring hospitalization, that may be related to overdoses due to dosing errors associated with compounded semaglutide injectable products.
A Michigan company is suing a telepharmacy that allegedly supplied fake Ozempic. New resources about the risks of compounded medicines. Details about the fake cancer drug ring busted in India.
New information on the patients recently hurt by counterfeit Botox, two news stories involving pill presses, and a prosecution announced in Austria over fake Ozempic that sent multiple people to the hospital.
The Cooper Davis and Devin Norring Act would force social media to report online drug sales. Additional news involves counterfeit cancer drugs sold in the U.S., fake cosmetic injections and more.
Adam Brosius, Patrick Boyd and Charles Boyd are facing eight counts for selling $90 million of diverted prescription drugs from five black-market suppliers.
On June 13, 2024, PSM sent a letter to Congressmen Darrell Issa and Jerrold Nadler applauding the reintroduction of the Stopping Harmful Offers on Platforms by Screening Against Fake E-Commerce (SHOP SAFE) Act.
Fake Ozempic has been found in Brazil, the U.K., and the U.S. Eli Lilly warned the public about fake and compounded tirzepatide medicines. Additional domestic and international stories.
Florida still has not imported a single pill, patients seeking GLP-1 medicines at increased risk from phishing scams, the counterfeit medicine news from three other countries.
“Lilly Warns Patients About Counterfeit and Compounded Medicines Releases Open Letter and Takes Further Legal Action Against Counterfeit, Fake, Unsafe, and Untested Products”
The FDA published its annual drug shortage report for 2023, CBP in Cincinnati seized multiple shipments of fake Ozempic, and international counterfeit medicine stories out of six different countries.
PSM submitted a letter to leaders in the New York State legislature opposing a legislative proposal (AB 7954) to setup a wholesale Canadian drug importation program. The bill died right before end of session.