ARTICLE
22 April 2025

FDA Issues Warning About Counterfeit Ozempic

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On Monday 14 April, the US Food and Drug Administration (FDA) issued a warning about hundreds of counterfeit Ozempic injections identified in the drug supply chain.
United States Food, Drugs, Healthcare, Life Sciences

On Monday 14 April, the US Food and Drug Administration (FDA) issued a warning about hundreds of counterfeit Ozempic injections identified in the drug supply chain.

The FDA seized counterfeit products on 9 April bearing the lot number PAR0362 and serial numbers starting with the digits "51746517". All seized products are being tested by the FDA and Ozempic manufacturer, Novo Nordisk. This follows a seizure of thousands of counterfeit units in December 2023.

The value of the counterfeit pharmaceutical industry is estimated to be around $4.4billion worldwide. The most common counterfeit pharma products are antibiotics, lifestyle drugs and painkillers and trade in these types of goods is largely facilitated by small packaging shipments (parcel post or letter packets) which can be very difficult for customs and border force authorities to detect.

Counterfeit pharma products are obviously highly dangerous for a few reasons – generally, there is either an incorrect amount of the active ingredient or no active ingredient present at all. These products may also contain a huge range of unsafe substances such as mercury, arsenic and rat poison.

The huge rise in demand for Ozempic has led to consumers looking to source the product as cheaply as possible, and to counterfeiters taking advantage of the opportunity, but there is obviously a huge consumer safety risk here.

FDA was notified by Novo Nordisk on April 3, 2025, that several hundred units of counterfeit Ozempic (semaglutide) injection 1mg were in the U.S. drug supply chain. The counterfeit products were distributed outside the Novo Nordisk authorized supply chain in the U.S. FDA seized the identified counterfeit products on April 9, 2025.

www.fda.gov/...

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