Counterfeit Ozempic Alert: FDA Confirms Fake Semaglutide in U.S. Supply Chain

Hundreds of Units Seized Amid Infection Risks and Legal Fallout and What Victims Need to Know Now

Ozempic (semaglutide) has become one of the most widely prescribed medications for managing type 2 diabetes and off-label weight loss. As its popularity has surged, so has the threat of counterfeit versions entering the U.S. market. In multiple public announcements from December 2023 through December 2025, the U.S. Food and Drug Administration (FDA) confirmed that counterfeit Ozempic injection 1mg pens have entered the legitimate drug supply chain in the United States.

The counterfeit products are being sold and distributed outside of Novo Nordisk’s authorized supply chain and present a direct threat to patient safety. FDA investigations are ongoing, but so far, thousands of counterfeit units have been seized, and additional shipments may still be circulating.

Although no confirmed adverse events have been tied directly to the counterfeit versions, the potential health risks—including contamination, unverified drug composition, and unsterile needles—are significant. Patients who unknowingly used counterfeit Ozempic may be at risk for infection, injury, or inadequate treatment of their underlying condition. For those affected, legal action may be necessary to recover damages and hold the responsible parties accountable.

FDA Confirms Presence of Counterfeit Ozempic in U.S. Drug Supply Chain

The FDA has confirmed multiple seizures of counterfeit Ozempic injection 1mg pens since December 2023. The most recent seizure occurred in late 2025 and involved units falsely labeled with lot number PAR1229, a number that also corresponds to genuine Ozempic. This overlap increases the risk of confusion for pharmacies, clinics, and consumers.

The key identifier for the counterfeit version of PAR1229 is the placement of the EXP/LOT text on the pen’s label:

• Counterfeit: EXP/LOT text appears on the left side of the expiration date and lot number.
• Authentic: EXP/LOT text is located above the expiration date and lot number.

Earlier counterfeit shipments were also identified under:

• Lot Number PAR0362 and serial numbers starting with 51746517
• Lot Number NAR0074 and serial number 430834149057

These counterfeit pens were not simply fakes sold on black markets—they infiltrated the legitimate U.S. drug supply chain, making their way into retail pharmacies and potentially reaching consumers under the appearance of legitimacy.

Health Risks Posed by Counterfeit Ozempic

Counterfeit medications pose dangers not just because they may be ineffective, but because they may contain unknown or hazardous ingredients. The FDA has confirmed that:

• The needles in the seized counterfeit Ozempic pens are non-authentic, raising concerns about sterility and infection risk.
• Other components, including the pen label, carton, and patient information inserts, were found to be counterfeit.
• The FDA does not yet know the exact composition of the seized drugs, leaving open the possibility that they contain no active semaglutide, contaminated substances, or even toxic compounds.

So far, the only adverse events reported have come from use of authentic Ozempic, but this does not rule out the possibility that harm has occurred from counterfeit products. Individuals who have experienced unexpected reactions after injecting Ozempic should not dismiss those symptoms.

Possible health risks include:

• Bacterial infections from unsterile needles
• Improper blood sugar control due to ineffective medication
• Toxic reactions to unidentified or harmful ingredients
• Liver, kidney, or gastrointestinal damage

These risks are especially dangerous for vulnerable populations such as elderly individuals, patients with immune deficiencies, and those with multiple underlying conditions.

How Counterfeit Medications Enter the U.S. Supply Chain

Counterfeit drugs typically infiltrate the supply chain through:

• Unauthorized distributors
• Gray market sellers
• Unregulated online pharmacies
• Wholesalers operating without proper oversight

In the case of Ozempic, the FDA has indicated that the counterfeit units were distributed outside of Novo Nordisk’s authorized supply chain, but still found their way into otherwise legitimate channels. Pharmacies may unknowingly stock these products if they purchase from third-party sellers not vetted by the manufacturer.

This incident has prompted the FDA to advise all:

• Retail pharmacies
• Wholesalers
• Health care professionals

…to verify the source of all Ozempic shipments and only purchase from authorized Novo Nordisk distributors. Pharmacists are encouraged to inspect lot numbers, packaging details, and contact Novo Nordisk if they suspect counterfeit stock.

What Consumers Can Do to Identify Counterfeit Ozempic

Patients who use Ozempic are advised to take the following steps immediately:

1. Check the Lot Number: Review the lot number and serial number printed on your Ozempic pen or packaging.
2. Look at the Label Placement: If the EXP/LOT text is located to the left of the expiration date, it may be counterfeit.
3. Confirm Source of Purchase: Only use Ozempic obtained through state-licensed pharmacies with a valid prescription.
4. Contact Novo Nordisk: If you are unsure whether your product is authentic, call Novo Nordisk at 1-800-727-6500.

If a counterfeit product is suspected, do not use it. Set it aside safely and consult your doctor and pharmacy immediately. Patients who suffer side effects or develop infections after using the drug should document their symptoms and seek medical attention.

FDA’s Ongoing Investigation and Enforcement Actions

The FDA’s investigation is ongoing and is part of a larger effort to monitor counterfeit pharmaceuticals in the U.S. drug supply. So far:

• Thousands of counterfeit Ozempic pens have been seized.
• FDA and Novo Nordisk are conducting chemical testing and analysis on the seized products.
• Multiple alerts have been issued to health care providers, pharmacies, and the public.

The agency is also working in coordination with federal law enforcement and customs officials to trace the source of these counterfeit shipments and prosecute parties responsible for their distribution.

Patients and providers are being urged to report any adverse events related to counterfeit Ozempic through the FDA MedWatch Program, and entities knowingly selling fake semaglutide are subject to criminal penalties.

Legal Options for Victims of Counterfeit Ozempic

Consumers who have suffered harm after using a counterfeit Ozempic injection may be eligible to pursue legal claims. Even if no serious physical injury occurred, the use of an unapproved and untested drug poses clear safety and liability issues. Potential claims include:

• Product Liability: Holding distributors and sellers accountable for placing unsafe products into the stream of commerce.
• Negligence: Against pharmacies or intermediaries who failed to verify the authenticity of the drug.
• Medical Injury Claims: If a counterfeit product caused health complications, including infections or uncontrolled diabetes.
• Consumer Protection Violations: Including deceptive practices or failure to warn.

In wrongful death cases where a counterfeit drug led to a fatal reaction or infection, surviving family members may pursue wrongful death claims.

Victims may be able to recover compensation for:

• Medical bills
• Lost wages
• Pain and suffering
• Long-term health complications
• Funeral expenses (in fatal cases)

Counterfeit Ozempic Lawsuit FAQs

How do I know if I received counterfeit Ozempic?

Check your Ozempic pen’s lot number and the placement of the EXP/LOT text. If the text is on the left side of the expiration date and matches lot number PAR1229, PAR0362, or NAR0074, your medication may be counterfeit.

What risks come with counterfeit semaglutide?

The primary risks include infection from non-sterile needles, ineffective treatment, exposure to unknown chemicals, and complications from untreated diabetes or obesity.

Is there an FDA-approved way to verify my Ozempic is real?

Yes. Only purchase from licensed pharmacies that buy directly from authorized Novo Nordisk distributors. You can contact Novo Nordisk directly for verification.

Can I file a lawsuit if I used counterfeit Ozempic?

If you experienced health issues, complications, or emotional distress from unknowingly using counterfeit medication, you may have a claim. Legal options vary depending on your injuries and where the drug was purchased.

Can pharmacies be held responsible for dispensing counterfeit medications?

Yes. If a pharmacy fails to confirm that its products are sourced through legitimate supply chains, it can be held liable under product liability and negligence laws.

What compensation could I receive from a lawsuit?

Depending on the severity of your case, compensation may include medical expenses, lost wages, costs for future care, and damages for pain and suffering.

Contact Parker Waichman LLP For A Free Case Review

If you or a loved one used Ozempic and suspect you may have received a counterfeit product—or suffered unexpected side effects, legal help is available. You may be entitled to financial compensation for medical bills, pain, or long-term complications.

Parker Waichman LLP is a national personal injury law firm investigating cases involving counterfeit semaglutide products.

Call today for a FREE consultation at 1-800-YOUR-LAWYER (1-800-968-7529).

There is no cost to speak with a lawyer, and your rights deserve immediate protection. Don’t wait, take action now to hold those responsible accountable. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you.