Counterfeit drugs and the US supply chain

On Oct. 16, 2026, FDA warned that counterfeit versions of over-the-counter eye drops had turned up in Florida and Georgia, in stores serving mainly Spanish-speaking customers, and might also be on shelves in Louisiana, Mississippi and North Carolina. Laboratory testing found bacterial contamination in two of the products, the agency said², and it was working with distributors "to identify, investigate and remove unlawful eye drops found in the U.S. drug supply."

It was the latest entry on a short list, and a different problem from the 2023 eye drop recalls, which involved contaminated products rather than fakes. FDA's counterfeit medicine page¹ lists seven notices posted since April 2023. Three concern fake pens of a brand-name semaglutide injection, and FDA's own warning about that product has been updated twice as new batches turned up in the prescription supply chain.

Counterfeits are rare in US pharmacies, and the federal system is built to keep it that way. They are also not zero, and they cluster in predictable places, among them high-priced or high-demand products, goods in shortage, over-the-counter items outside prescription tracing rules, and websites posing as pharmacies. This piece covers how FDA defines the problem, the safeguards in the Drug Supply Chain Security Act (DSCSA), what recent cases show, and the agency's warnings about buying medicine online.

What FDA counts as counterfeit

FDA describes counterfeit medicines as fake or falsified products passed off as authentic that "may contain the wrong ingredients, contain too much, too little or no active ingredient at all or contain other harmful ingredients." The agency also says "the U.S. drug supply is among the safest in the world," because federal and state laws create a "closed" distribution system, in which drugs move between licensed manufacturers, distributors and pharmacies.

Federal tracing law puts counterfeits inside a wider legal category. A "suspect product" is one with "reason to believe" it is counterfeit, diverted or stolen, intentionally adulterated, the subject of a fraudulent transaction, or otherwise unfit for distribution. Once "credible evidence" confirms any of those, it becomes an "illegitimate product," FDA's 2021 guidance on suspect products⁴ explains.

For the global picture, the World Health Organization uses a different frame, separating substandard products (made badly) from falsified ones (made to deceive). Its fact sheet¹⁰ estimates that "at least 1 in 10 medicines in low- and middle-income countries are substandard or falsified."

Recent US cases

Our table lists every notice on FDA's counterfeit medicine page as of early November 2026, with FDA's semaglutide warning split into its three dated updates. Products are described by type, and several of the notices came from the brand owners.

Semaglutide shows the pattern FDA's guidance warns about. In its December 2023 notice³, the agency said it had "seized thousands of units" and that the counterfeit pen label, carton, patient information and needles were all fakes. The April 2025 batch, several hundred units, was "distributed outside" the manufacturer's authorized supply chain. In December 2025, FDA said dozens more units "were in the legitimate U.S. drug supply chain" and carried a lot number that "also is an authentic lot number," so the giveaway was the position of small print on the label. The demand surge around that drug class is the subject of our piece on GLP-1 shortages.

None of the entries is a low-cost prescription generic. FDA's guidance lists the risk factors for suspect product, among them items "generally in high demand," products with "a high sales volume or price," prices "too good to be true," and products "the subject of a drug shortage." That profile fits few of the inexpensive generic tablets that fill most US prescriptions, though drugs in shortage are an exception, and our shortage tracker lists the current ones.

How the DSCSA is supposed to catch them

Signed Nov. 27, 2013, the DSCSA built a package-level tracing system over 10 years. FDA describes its aim as a way to "identify and trace certain prescription drugs at the package level," which the agency says helps prevent, detect and remove⁵ harmful drugs. Each package carries a product identifier with the National Drug Code, serial number, lot and expiration date, and each sale passes tracing records to the buyer. Our explainer on the DSCSA and serialization walks through those records.

When something looks wrong, the law sets a clock. Manufacturers, repackagers, wholesale distributors and dispensers must quarantine a suspect product while they investigate. If they determine it is illegitimate, they must notify FDA and their immediate trading partners "within 24 hours," FDA's notification page⁶ says, using Form FDA 3911 or its electronic version. Manufacturers face an extra duty to notify within 24 hours when a product is at "high risk" of being illegitimate.

Two limits are built into the system. Tracing applies to certain prescription drugs, so over-the-counter eye drops on a store shelf fall outside it. And full electronic compliance is still being phased in for the smallest pharmacies. In August 2026, FDA extended exemptions⁷ for small business dispensers, those with 25 or fewer full-time pharmacists and technicians, until Nov. 27, 2027.

Counterfeits also rarely show up in recall data, because the legitimate maker has no product to recall. GxRadar searched all 18,076 drug recall records in FDA's enforcement database¹² from June 2012 through Oct. 28, 2026, and found none whose stated reason mentions counterfeiting. Those cases run through seizures, public alerts and FDA's Office of Criminal Investigations. Our recalls page and guide to checking whether a medicine was recalled cover the quality problems that do generate recalls.

The online pharmacy problem

The larger exposure for consumers sits outside the closed system. "At any given time, there are roughly 35,000 active online pharmacies," and about 5 percent of those comply with US pharmacy laws and practice standards, according to figures from the national association of state pharmacy boards that FDA cites in its BeSafeRx FAQ⁸. FDA says unsafe sites "are often run by criminal networks."

FDA's BeSafeRx campaign lists the warning signs of an unsafe site⁹. According to the agency, a site may be unsafe if it:

• does not require a prescription
• is not licensed in the US and by the buyer's state board of pharmacy
• has no licensed pharmacist available to answer questions
• sends medicine that looks different, arrives damaged or in a foreign language, or has no expiration date
• offers prices that seem too good to be true

FDA's list of safe signs mirrors it, with a required prescription, a US physical address and phone number, a licensed pharmacist on staff and a state pharmacy license. Our pharmacy finder lists pharmacies by ZIP code from the federal NPI registry, and a state board of pharmacy can confirm a license.

A separate and deadlier market involves fake pills sold outside any pharmacy. CDC researchers reported in 2023¹¹ that the share of overdose deaths with evidence of counterfeit pill use rose from 2.0 percent in July to September 2019 to 4.7 percent in October to December 2021, and from 4.7 percent to 14.7 percent in western states. Illicitly made fentanyl was the only drug involved in 41.4 percent of the deaths with evidence of counterfeit pills, the report found.

FDA asks consumers and health professionals to report suspected counterfeits through MedWatch and suspected criminal activity to its Office of Criminal Investigations, both linked from the counterfeit medicine page¹. Anyone unsure whether a package looks right can ask a pharmacist to compare it with the product the pharmacy normally stocks. The next date on the calendar is Nov. 27, 2027, when the small-dispenser exemptions end and package-level electronic tracing is due to reach the smallest pharmacies.