The U.S. Food and Drug Administration (FDA) has issued a warning about counterfeit Ozempic 1mg injections circulating through unauthorized distributors. The discovery was made after drugmaker Novo Nordisk reported the infiltration of fake products in the U.S. supply chain.

Key Highlights:

Counterfeit Ozempic Discovered Outside Authorized Channels

• Novo Nordisk informed on April 3 that counterfeit 1mg Ozempic injections were being sold through illegal channels.

• FDA confiscated several hundred units of the fake product on April 9.

Product Information and Potential Risks Identified

• Fake products carried lot number PAR0362 and serial numbers beginning with 51746517.

• Six reports of adverse events were associated with the lot, although none are proven to be from the counterfeit version.

Investigation and Testing Underway

• FDA and Novo Nordisk are also testing the counterfeit products for safety.

• Authentic Ozempic induces side effects such as stomach discomfort, leaving cause of adverse events uncertain.

Continued Risk due to High Demand and Off-Label Use

• The warning calls attention to the increased popularity of GLP-1 medications such as Ozempic, which are used off-label for weight loss.

• The FDA had earlier seized thousands of counterfeit Ozempic units in December 2023 and issued a warning regarding continued risk.

Clarification on Compounded Versions

• Counterfeit products are distinct from compounded preparations, which are legally allowed in some situations such as medication shortages.

• FDA had reported in February 2025 that shortages of Ozempic and Wegovy had been resolved, restricting usage of compounded substitutes.

The FDA warning about spurious Ozempic highlights the critical issues of supply chain integrity and patient safety. With GLP-1 medication demand at an all-time high, the agency recommends healthcare professionals and patients to check product authenticity and report suspicious batches instantly.