FDA seizes counterfeit Ozempic pens sold with a real lot number

The FDA said on Dec. 5, 2025, that it recently seized dozens of units of counterfeit Ozempic (semaglutide) injection 1 mg that had been sold outside Novo Nordisk's authorized supply chain and reached the legitimate U.S. drug supply chain ^[1][2]. The agency told patients not to use a pen whose label places the "EXP/LOT" text to the left of the expiration date and lot number ^[1][2].

The case is unusual because the lot number itself is genuine. The seized pens are labeled lot number PAR1229, and PAR1229 is also a real Ozempic lot number, so the digits alone do not mark a product as fake ^[1][2][3]. The distinguishing feature is label layout. Authentic pens print EXP/LOT above the expiration date and lot number; the counterfeit version prints it to the left ^[1][2][3].

One group is not affected. Ozempic injection 1 mg with lot number PAR1229 dispensed through the Novo Nordisk Patient Assistance Program is authentic product and may continue to be used, according to the FDA and the company ^[1][2].

Investigators have not established what the counterfeit pens contain. FDA said testing and analysis are underway to determine the drug's composition and safety risks ^[1]. Novo Nordisk said the work will include extensive visual examination and planned chemical testing, and that neither the company nor the FDA can confirm the contents or quality of the seized product, which may present a safety risk to anyone who uses it ^[2]. The Partnership for Safe Medicines, a nonprofit that tracks counterfeit drugs, noted that FDA does not yet know the identity, quality, sterility or safety of the product ^[3].

FDA is aware of six adverse event reports tied to this lot, but the agency said those reports involve authentic Ozempic and none appear to be linked to the counterfeit pens. Novo Nordisk submitted all six ^[1].

Novo Nordisk alerted FDA on Nov. 18, 2025, that counterfeit Ozempic 1 mg was in the legitimate supply chain ^[1]. It is the third such case the agency has posted about in roughly two years. In April 2025, FDA seized several hundred units labeled with lot number PAR0362 and a serial number beginning 51746517, after Novo Nordisk's April 3 notification; six adverse events were reported for that lot and none appeared to involve the counterfeit product ^[1]. In December 2023, the agency said it had seized thousands of units labeled NAR0074 with serial number 430834149057, and analysis showed the needles were counterfeit, so their sterility could not be confirmed, a finding FDA said raised infection risk. Five adverse events were reported from that lot, none serious ^[1][3].

Why it matters for patients

Counterfeit Ozempic has now appeared in the same distribution channel that supplies ordinary U.S. pharmacies, rather than only in packages bought from unfamiliar sellers ^[1]. Because laboratory work is incomplete, no one has confirmed what is inside the seized pens or whether they are sterile ^[1][2][3].

FDA advised patients, wholesalers, retail pharmacies and prescribers to inspect the Ozempic they have on hand and to avoid using, distributing or selling anything with the counterfeit label layout ^[1]. Retail pharmacies were urged to buy Ozempic and other semaglutide products only from authorized Novo Nordisk distributors, and pharmacists unsure about a batch can call Novo Nordisk customer care at 1-800-727-6500, Monday through Friday, 8:30 a.m. to 6 p.m. EST ^[1][2]. The agency's guidance for patients is to obtain Ozempic only with a valid prescription through a state-licensed pharmacy and to examine the product before using it ^[1]. Novo Nordisk said it believes the risk of receiving counterfeit medicine is minimized when a prescription is filled by a legitimate retailer that uses its authorized distributors ^[2].

Suspected counterfeit product can be reported to an FDA consumer complaint coordinator or through the agency's suspected criminal activity channel, and side effects can go to FDA's MedWatch program at 1-800-FDA-1088 or to Novo Nordisk at the customer care number above ^[1][2].

What happens next

FDA's investigation continues, and the agency said it is working with Novo Nordisk to identify, investigate and remove further suspected counterfeit Ozempic injectable products from the U.S. supply ^[1]. No date has been given for the testing results, and no additional lot numbers have been announced in this case beyond PAR1229 ^[1][2].