FDA Seizes New Batch of Counterfeit Ozempic as Supply Chain Scrutiny Intensifies

Dave Knapp
14 hours ago
3 min read

Original posted at obesity.news/ on Dec 08, 2025

The FDA has again intercepted counterfeit Ozempic in the United States drug supply, marking the second confirmed incident this year and underscoring ongoing vulnerabilities in a market defined by record demand for GLP 1 products.

In a notice published December 5, the agency reported seizing dozens of counterfeit Ozempic 1 mg pens labeled with lot number PAR1229. That lot number corresponds to a legitimate Novo Nordisk batch, which made the discovery more concerning. The pens were distributed outside Novo’s authorized supply chain but still made their way into the legitimate United States channel.

The only reliable marker for identifying the falsified products is the placement of the EXP and LOT text on the label. Counterfeit pens display this text on the left side of the expiration date. Authentic pens show the text above it. The agency is instructing patients and pharmacies to avoid any product where that detail is not correct.

Novo Nordisk confirmed that patients enrolled in its Patient Assistance Program who received pens from lot PAR1229 are not affected. Those pens were sourced directly from Novo and are authentic.

The FDA noted six adverse events associated with the PAR1229 lot, all reported by Novo and all tied to authentic Ozempic rather than the counterfeit supply.

A recurring issue in 2025

This is the second time this year the FDA has confirmed counterfeit Ozempic entering the United States distribution system.

On April 3rd, Novo Nordisk alerted the agency to several hundred falsified Ozempic 1 mg pens labeled with lot PAR0362 and serial numbers beginning with 51746517. Those units were also found in the legitimate domestic supply chain. The FDA seized them on April 9th.

As with the December incident the agency reported 6 adverse events linked to that lot. None were attributed to the counterfeit pens.

Testing for both sets of seized materials is ongoing. Neither the FDA nor Novo has disclosed data on composition or safety implications.

Why it matters

Counterfeit GLP 1 products have become a recurring issue as demand for incretin based therapies accelerates. Earlier cases involved unauthorized online sellers and international gray markets. The challenge facing regulators now is that falsified units have penetrated the licensed United States drug distribution system.

That is the part raising the most concern inside industry circles. Authorized distributors are supposed to represent the secure side of the supply chain. Any breach particularly for a high demand injectable like semaglutide prompts questions about the upstream sourcing, credentialing, and verification steps.

The agency is urging pharmacies to buy Ozempic only from distributors authorized by Novo Nordisk and to review all incoming shipments for label inconsistencies. Pharmacists with concerns are instructed to contact Novo directly.

Patients are being advised to obtain Ozempic exclusively through state licensed pharmacies, verify packaging details, and report any suspected issues.

What comes next

The FDA’s investigation includes analytical testing of the seized product to determine whether it contains semaglutide, counterfeit excipients, incorrect dosages, or contaminants. Results have not yet been made public.

The agency states it is working with Novo Nordisk and other federal partners to identify any remaining units and remove them from circulation. Novo has published parallel notices on its website and continues to report adverse events linked to suspect lots.

The real concern is whether these two incidents represent isolated leaks or the continual flow of these types of stories signals broader vulnerabilities in the GLP-1 supply chain, and the broader prescription drug market. It begs the question, “How many other medicines people are getting from their pharmacy are fake?”