Prescription Drug Freight Fraud Report, November 2025
Our latest analysis of FDA import records shows a continuation of the troubling patterns we’ve been documenting since February. From September 1 to October 31, 2025, large-scale freight fraud involving GLP-1s, oncology drugs, and other high-demand pharmaceuticals continued unabated, and in several areas it became more brazen than what we documented in earlier reporting. Our standard analysis focuses on semaglutide, tirzepatide, and things coded as antibiotics. We also analyze other medicines in each report; for this analysis, we pulled shipment data for etanercept (Enbrel) and dapagliflozin (Farxiga). We identified hundreds of entries linked to unregistered or outright illegitimate facilities, including chemical exporters with no pharmaceutical credentials, foreign unlicensed compounding pharmacies illegally shipping into the U.S., and individuals using residential addresses as manufacturers, or shipments trying to conceal their content.
Read more:
Knockoff weight loss drugs from illegal foreign sources (PSM report, March 2025)
Review previous updates on our pharmaceutical border security page
In total, we reviewed 859 shipments of semaglutide, tirzepatide, etanercept, and dapagliflozin. In these shipments, we found that 159 were from illegitimate manufacturers. Of shipments from illegitimate facilities, ~75% of semaglutide was released, ~95% of tirzepatide was released, 75% of Enbrel was released, and ~94% of Farxiga was released. Of the 519 antibiotic shipments, we flagged 110 for potential code fraud. Of these 110 shipments, 51 were from illegitimate manufacturers, and all of them were released.
In October, the federal government was shut down, and FDA personnel were operating under strained conditions. Even in normal months, the agency must triage overwhelming freight volumes with limited resources; during a shutdown, the vulnerabilities only widen. The freight we tracked during this period makes clear how vital stable FDA funding is and how urgently the agency needs destruction authority to intercept and eliminate fraudulent shipments rather than allowing repeat resubmission attempts. (See PSM’s joint letter to Congress with other patient advocacy groups asking for the FDA to have destruction authority.)
What we found
Shipments of API from unregistered facilities
While there were many irregularities in shipments of API into the U.S., many of those we found were edge cases, including:
- Several shipments of semaglutide with an invalid FEI and for a manufacturing entity that does not have a registration for a facility with the FDA, but is a well-known third party logistics provider (Livlina) in Europe that may be an authorized logistics provider for Novo Nordisk.
- Two kilogram-sized shipments of semaglutide marked as investigational from a manufacturer that has registered facilities (Zydus), but did not provide a complete enough address to confirm it was from an FDA-registered facility. (We also observed a similar problem with shipments from Cipla)
We are limited in what we can see about each shipment. We don’t have access to the weight of the package, for example, which would tell us more: a 20 lb package labeled “mounjaro” is likely quite a lot of pens or API, whereas a 0.5 kg package may just be one finished product.
We also are not privy to the supply chains of manufacturers, so we cannot know who is and isn’t a legitimate manufacturing entity or third party logistics provider.
Bottom line: we did not see any blatantly problematic API shipments this month.
Farxiga focus
We found a significant number of shippers of personal-sized quantities of Farxiga, if we’re to believe the ITACS descriptions are accurate. Without independent data about the weight of the shipments, we can go no further.
The variety of shipments of Farxiga declared as manufactured by individuals suggests there is a healthy supply chain of diverted and/or counterfeit Farxiga in the trackable freight shipment stream. There is probably even more in the stream of packages that used to be called “de minimis..
Our most interesting shipments were declared as made by Vida Natural in Brazil, a compounding pharmacy that sells its products online. They had four shipments with an FDA product code that corresponds to the ingredient name for Farxiga (dapagliflozin), including one described as 1.0 kilogram. Vida Natural is not an FDA-registered facility, and one of the FEI numbers used for two of these shipments is not valid. The other FEI code has had six refusals for shipments this year, though none of these four in our study period were refused.
Two of the other Vida Natural’s declared product shipments had product codes for Dapagliflozin, but the ITACS description was something else entirely:
- 5-HTP (5-hydroxytryptophan): a naturally occurring amino acid and a precursor to the neurotransmitter serotonin; and
- Capsiate is a non-pungent compound (a capsinoid) found in a special sweet pepper variety, CH-19 Sweet, that mimics some of capsaicin's effects (like boosting metabolism and fat burning) but without the spicy heat, making it popular in dietary supplements for weight management and metabolic health.
All these shipments were allowed entry.
Enbrel focus
We only found 19 shipments coded as Enbrel in the shipment stream during our study period, none of which were large quantities. Three caught our eye:
- One shipment was declared as being made at a Mexican pharmaceutical company, Ultra Laboritorios, in Guadalajara, Mexico. They are not an authorized manufacturer of Enbrel that we could find in public records, and the shipper used a non-existent FEI number.
- Two shipments were declared as made by “SATYANARAYANA MURTHY AKELLA,” which is more likely a person than a pharmaceutical manufacturer. The address of the manufacturing site is a sports complex in India, which is likely not a or a drug maker.
Residential "manufacturing"
One of the most striking patterns of the September–October dataset is the rise of shipments supposedly manufactured in ordinary residential properties. We documented semaglutide and tirzepatide shipments assigned to suburban homes, apartments, strip-mall suites, and unmarked duplexes, even a construction company office across the world. The pattern existed in our data for Farxiga as well.
There are several possibilities for the reason to list a small office or residential address as the manufacturer of shipments of drugs. All of these theories do not meet the requirement that the legitimate manufacturer be listed, but they may explain why the sender incorrectly filled out the paperwork this way:
- It’s for a Canadian on a long-term visit to the U.S.: The name and address may be for a relative or friend sending the medicine to the patient who is vacationing in the U.S.
- It’s a straw-man sender for a larger scheme: Individuals are paid to use their own information to fill out shipments for Canadian IPS pharmacies.
- Individual entrepreneurs: Individual Canadians who are trafficking medicine to U.S. patients feel compelled to put their own address on the shipment.
- Completely fabricated: The addresses and names are picked at random. We have attempted to verify these names and addresses, and many of them appear to match some available public records, but it’s not clear they are even aware of their presence on the package.
Regardless of the intent, the danger is the same: shipments that state they were made in residential structures cannot be traced to a legitimate manufacturer and have no validated environmental controls, no sterility safeguards, and no oversight of how the drugs were stored, handled, or repackaged. Anything released from these locations represents a direct threat to the integrity of the supply chain.
Foreign prescription delivery services
During September and October, Pharmazon in the United Kingdom, a prescription delivery service, not a drug manufacturer, appeared as the declared producer of five GLP-1 shipments.
In the case of Pharamazon, all five shipments were stopped. We checked the Internet archive, and its website changed to say they stopped accepting international orders in May 2024, though clearly this manifest suggests they shipped some during this period.
We also found two shipments from an address next to the Winnipeg airport in Canada that is listed on the pharmacy.cloud website, an internet pharmacy service (IPD) licensed in Manitoba. The manufacturer is alternately listed as PDC and “pharmacy dot cloud”. Neither is registered as a facility with the FDA.
IPS pharmacies are a special, controversial license for Internet Prescription Services issued by the College of Pharmacists for Manitoba for entities that dispense mail-ordered medicines coming from all over the world to patients all over the world.
One shipment is registered as importing 1.81 kilograms of Ozempic. Given its proximity to the airport, we question whether they are just brokering in foreign medication or stealing from the Canadian drug supply. Either scenario poses safety risks for Americans and possibly also Canadians. Without a valid FDA-registered manufacturing site, it should be refused. Additionally, the FEI provided is not a registered one. It’s unclear whether they made it up or if it is a retired FEI that they still use.
High-value drugs hidden behind low-risk codes
The final pattern we documented is the continued use of fraudulent product coding, in which high-risk or high-value pharmaceuticals are coded as low-risk antibiotics. September and October were no exception: dozens of antibiotic-coded shipments contained oncology drugs, transplant immunosuppressants, psychiatric medications, corticosteroids, or other unrelated products. We think antibiotic codes are appealing to counterfeiters because they believe they receive less scrutiny.
One such case includes Azacitidine, a drug used to treat acute leukemia, labeled as an antibiotic from an unregistered facility, which was let into the country. This wasn’t the only oncology drug we found. Everolimus, dexamethasone, and vinblastine were also found in the September and October imports.
Our research process
To produce this report, we analyzed large-scale commercial imports of semaglutide, tirzepatide, Enbrel, Farxiga, and antibiotics from September and October 2025, using the FDA’s Imports Database, list of registered drug establishments, and Product Code Builder; the Import Trade Auxiliary Communications System (ITACS); Google Maps; and manufacturer websites.
Access to our data
PSM makes our shipment-level data available to a group of manufacturer brand protection teams, law enforcement, and regulators.
Our policy recommendations
Short term:
- Shipments with an invalid FEI number should be refused or detained without physical examination.
Medium term:
- FDA should be given the authority to mandate the destruction of violative shipments whose manifest states they were made in non-FDA-registered facilities. Shippers should pay the cost of destruction and present proof of destruction to the FDA.
- FDA and CBP should refuse or detain shipments of medical products whose manifest claims that they were manufactured at a site that is not a registered FDA facility.
Long term:
- CBP should be allowed to process, refuse, detain, and mandate the destruction of shipments that cannot be released because they violate the Food, Drug, and Cosmetic Act. Currently, they can only act on trademark violations and controlled substance violations (through an MOU with the Drug Enforcement Administration). Adding their manpower to the FDA’s will keep Americans safer.