FDA seizes counterfeit Ozempic labeled with authentic lot number PAR1229

The U.S. Food and Drug Administration said on Dec. 5, 2025, that it seized dozens of units of counterfeit Ozempic (semaglutide) injection 1 mg that had been distributed illegally outside Novo Nordisk's authorized supply chain and had reached the legitimate U.S. drug supply chain ^[1]. The fake pens are labeled with lot number PAR1229 — which is also a real Novo Nordisk lot number ^[1][2].

Because the lot number alone does not tell real from fake, FDA and Novo Nordisk pointed to one visual difference on the pen label. On the counterfeit pens, the "EXP/LOT" text appears to the left of the expiration date and lot number. On authentic Ozempic pens, that text appears above the expiration date and lot number ^[1][2]. FDA said patients should not use Ozempic if the EXP/LOT text appears on the left side ^[1].

Novo Nordisk added an important exception: Ozempic 1 mg with lot number PAR1229 obtained through the Novo Nordisk Patient Assistance Program is authentic and is not counterfeit ^[1][2]. The company said the product is counterfeit only when that lot number is paired with the misplaced EXP/LOT text ^[2].

What is known about the contents

Not much, yet. FDA said testing and analysis of the seized products are underway to determine the drug's composition and safety risks ^[1]. Novo Nordisk said visual examination found counterfeit features, but the product's composition "has not been conclusively determined at this time," and that further work, including extensive visual examination and planned chemical testing, is still to come ^[2]. Because of that, neither the company nor FDA can confirm the contents or quality of the counterfeit product, "which may present a safety risk for patients who use the counterfeit product" ^[2]. The Partnership for Safe Medicines summarized the same gap, noting the identity, quality, sterility and safety of the seized units are not yet known ^[3].

FDA said it is aware of six adverse event reports associated with lot PAR1229. The agency said those events are associated with authentic Ozempic and none of them appear to be associated with the counterfeit product. All six were reported by Novo Nordisk ^[1].

The timeline: Novo Nordisk notified FDA on Nov. 18, 2025, that counterfeit Ozempic 1 mg was in the legitimate U.S. supply chain ^[1]. The public alert followed on Dec. 5 ^[1][2].

Not the first time

This is at least the third counterfeit Ozempic episode FDA has flagged in the same alert page. In April 2025, Novo Nordisk told FDA that several hundred units of counterfeit Ozempic 1 mg labeled with lot PAR0362 and serial numbers starting 51746517 were in the supply chain; FDA seized them on April 9, 2025, and again reported six adverse events, none apparently tied to the fakes ^[1]. In December 2023, FDA seized thousands of units labeled with lot NAR0074. In that case, analysis found the needles were counterfeit and their sterility could not be confirmed, raising infection risk, along with fake pen labels, cartons and patient information ^[1].

Why it matters for patients

A counterfeit that copies a real lot number removes the shortcut many people use to check a medicine. In this case the only publicly described tell is the position of a few characters on the pen label ^[1][2][3]. Because chemical testing is not complete, no one can yet say what is inside these pens — whether it contains semaglutide, a different drug, the wrong amount or nothing active at all ^[2][3].

FDA said pharmacies should buy Ozempic only through Novo Nordisk's authorized distributors and check shipments, and that patients should obtain Ozempic only with a valid prescription through state-licensed pharmacies, checking the product for signs of counterfeiting before use ^[1]. Pharmacists or patients with questions about whether a batch is authentic 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]. Side effects or suspected counterfeits can be reported to FDA's MedWatch program online or by fax at 1-800-FDA-0178 ^[1], and suspected counterfeit sellers can be reported through FDA's criminal activity reporting page ^[2].

What happens next

FDA said its investigation is ongoing and that it is working with Novo Nordisk to identify, investigate and remove further suspected counterfeit semaglutide injectable products found in the U.S. ^[1]. The agency has not published a date for when the laboratory results on lot PAR1229 will be released ^[1].