FDA Issues Alert on Fake Ozempic—How to Tell If Yours Is Real

Buyer beware. The Food and Drug Administration is informing radical to ticker retired for shipments of counterfeit Ozempic that are presently flooding the market.

The FDA and Ozempic shaper Novo Nordisk jointly issued an alert astir the fakezempic past week. Several 100 units of the counterfeits are thought to person entered the cause proviso chain. It’s not wide whether these units contiguous a unsocial information hazard astatine this point, but regardless, the FDA is telling patients, pharmacies, and doctors not to usage oregon administer them if identified.

According to the alert, Novo Nordisk archetypal notified the FDA astir the counterfeit drugs connected April 3, which were distributed extracurricular the company’s authorized proviso concatenation successful the U.S. The FDA says it managed to prehend immoderate of these drugs connected April 9. The products tin beryllium identified by a operation of the batch fig PAR0362 (an authentic lot) and a serial fig starting with the archetypal 8 digits 51746517 (not authentic).

The counterfeits are specifically labeled arsenic 1 milligram doses of Ozempic, which is approved to dainty benignant 2 diabetes. Since the support of Novo Nordisk’s Wegovy—a higher dose formulation of the aforesaid progressive constituent (semaglutide) approved for obesity— successful 2021, Ozempic has go a fashionable off-label medicine for value nonaccomplishment arsenic well.

The FDA has received six adverse lawsuit reports connected to this circumstantial batch of Ozempic (all submitted by Novo Nordisk), but nary person progressive the counterfeit products. Both the FDA and Novo Nordisk are investigating the seized counterfeit products, but they don’t yet person immoderate accusation connected the quality, safety, oregon individuality of the products.

This isn’t the archetypal clip that counterfeit Ozempic has reached the public. In 2023, the FDA and wellness agencies successful different countries reported a akin counterfeit problem, with the FDA seizing thousands of units that entered the U.S. proviso concatenation that year. In astatine slightest immoderate cases, the faux products really contained insulin, and several users were hospitalized with insulin overdoses arsenic a result. The FDA besides noted successful 2023 that the needles utilized to inject these drugs were counterfeit arsenic well, raising the hazard of improper sterilization. Last year, the World Health Organization sent retired its ain alert aft being notified of counterfeit batches being sold successful Brazil, the UK, and the U.S.

Then arsenic now, the FDA is informing radical to not instrumentality immoderate chances and to enactment distant from these faux products.

“The bureau advises patients, wholesalers, retail pharmacies and wellness attraction professionals to cheque the Ozempic products they person received and not use, administer oregon merchantability products” identified arsenic counterfeit, the FDA said successful its alert.