Beware of Fake Ozempic, FDA Warns

— Agency seized thousands of counterfeit units already

by
Kristen Monaco, Senior Staff Writer, MedPage Today
December 22, 2023

The FDA continues its investigation into counterfeit semaglutide (Ozempic) products — which may still be available for purchase — and has already seized thousands of units, the agency announced Thursday.

In its warning, the FDA instructed wholesalers, retail pharmacies, healthcare practitioners, and patients to check the product they have received and not distribute, use, or sell products labeled with lot number NAR0074 and serial number 430834149057.

The investigation specifically pertains to the 1-mg injectable, labeled under the brand name Ozempic, which is indicated for type 2 diabetes. The GLP-1 receptor agonist also comes in 0.5-mg and 2-mg doses for diabetes, as well as a 2.4-mg dose for weight loss under the brand name Wegovy.

Both the drug products and the needles are deemed counterfeit, bringing their sterility and quality into question and increasing the risk for serious infection. So far, the FDA knows of five adverse events from the lot, though none were deemed serious and were consistent with the gastrointestinal events associated with semaglutide.

Any adverse events associated with the drug should be reported to FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

To avoid counterfeit products, the FDA recommended retail pharmacies only purchase Ozempic through authorized distributors of Novo Nordisk and compare photographs of the products. As for patients, they should only obtain the drug with a valid prescription through state-licensed pharmacies and check the product for signs of counterfeiting before use.

Problems with counterfeit semaglutide have persisted throughout the year as the blockbuster drug shot to popularity. Back in June, maker Novo Nordisk warned of counterfeit semaglutide that was reportedly sold at a legitimate U.S. retail pharmacy that in fact contained insulin glargine instead of the GLP-1 agonist.