Two Indian nationals have been charged in Florida with smuggling counterfeit Ozempic obtained from unauthorized sources in China and selling it to U.S. drug distributors at deeply discounted prices, the Justice Department announced Sept. 29. The scheme allegedly continued after the FDA first warned the public about fake pens.
Prosecutors say the fakes came with counterfeit packaging, package inserts, pen labels, and needles meant to make buyers believe they were getting the real product. For the millions of Americans who inject semaglutide each week, the charges are a reminder that a fake pen can travel through business channels before it reaches a pharmacy counter.
About 1 in 8 U.S. adults say they are currently taking a GLP-1 drug, according to a KFF poll released in November 2025. Among current users, 56% said the drugs are difficult to afford, and about 17% said they got them from an online provider or website.
The Alleged Scheme Behind the Fake Pens
According to the indictment, Swapnadip Roy, 33, and Vicky Ramancha, 37, obtained counterfeit Ozempic from unauthorized sources in China from July 2023 to April 2024. The scheme allegedly continued even after the FDA seized some of the fakes in December 2023 and issued a public warning.
Each man is charged with one count of conspiracy to commit smuggling and to defraud the United States, three counts of smuggling, and two counts of selling counterfeit drugs and holding them for sale. Each faces up to 71 years in prison if convicted. Roy was extradited from Italy and made his first court appearance in Tampa. "An indictment is merely an allegation," the Justice Department said, and both men are presumed innocent unless proven guilty.
Acting FDA Commissioner Kyle Diamantas called counterfeit products in the American drug supply "a direct threat to public health and patient safety" in the FDA announcement.
Justin Green, assistant commissioner of the FDA's Office of Criminal Investigations, added, "Drug safety and quality do not begin or end at the U.S. border."
Warning Signs on a Suspect Pen
The FDA has flagged three counterfeit batches on its counterfeit Ozempic warning page. The first, from December 2023, involved 1 mg pens with lot NAR0074 and serial number 430834149057. In April 2025, the agency flagged 1 mg pens with lot PAR0362 and serial numbers starting with 51746517.
The most recent alert, from December 2025, involves 1 mg pens with lot PAR1229. That is also a real lot number, so the giveaway is the label. On the fakes, the words "EXP/LOT" are printed to the left of the expiration date and lot number, while authentic pens print them above.
The needles matter most. The FDA says the needles found with these fakes are counterfeit, so "the sterility of the needles cannot be confirmed, which presents an increased risk of infection." The agency has received adverse event reports tied to these lots, but none of the 2023 reports were serious, and none of the later reports were linked to the counterfeit product.
Patients can compare the lot and serial number on both the carton and pen against FDA alerts, check for unusual printing or packaging, and avoid using any pen that looks different from earlier refills. Novo Nordisk customer care can be reached at 1-800-727-6500 to check a suspect product.
Checking a Pharmacy Before You Pay
The FDA says patients "should only obtain Ozempic with a valid prescription through state-licensed pharmacies and check the product before using for any signs of counterfeiting." A licensed pharmacy lowers the risk, though this case shows fakes can move through wholesale channels, so checking the pen still matters.
Legitimate online pharmacies require a prescription, list a physical U.S. address and phone number, have a licensed pharmacist on staff, and are licensed by a state board of pharmacy, according to the FDA's guide on buying medicines safely online. Shoppers can check a license through the FDA's BeSafeRx tool or their state board of pharmacy.
The National Association of Boards of Pharmacy says nearly 95% of websites offering prescription-only drugs online operate illegally. Its safe-buying guide warns against sites offering discounts that seem too good to be true, or that accept only cryptocurrency or peer-to-peer payments. Sites ending in .pharmacy are accredited by the group.
Anyone who used a suspect pen and develops redness, swelling, or pus at the injection site, fever, or unusual symptoms should contact a clinician. Severe allergic reactions or trouble breathing need emergency care. Problems can be reported through the FDA's MedWatch reporting program at 1-800-FDA-1088. Reports help investigators trace the source, even if no harm occurred.
The new charges cover past conduct, not a new wave of fakes. MedicalDaily will follow the case as it moves through federal court.
Key Questions Answered
What are the two men charged with? Conspiracy, smuggling, and selling counterfeit drugs tied to fake Ozempic allegedly obtained from China. The charges are allegations and have not been proven.
Did the fake Ozempic reach patients? Prosecutors say the fakes were sold to U.S. distributors. The FDA has received adverse event reports, but none were serious or linked to the counterfeit product.
Which lots are counterfeit? The FDA has flagged lot NAR0074, lot PAR0362 with serials starting 51746517, and lot PAR1229 pens with "EXP/LOT" printed to the left of the date and lot.
Is a licensed pharmacy completely safe? It is the safest option, but checking the pen and packaging is still wise.
How can I verify an online pharmacy? Use the FDA's BeSafeRx tool or your state board of pharmacy, and confirm the site requires a prescription.
What should I do with a suspect pen? Do not use it. Contact the pharmacy, call Novo Nordisk, and report it to FDA MedWatch.
Published by Medicaldaily.com
