Warning Issued After FDA Seizes Counterfeit Ozempic Products

Warning Issued After FDA Seizes Counterfeit Ozempic Products

Dangerous counterfeit Ozempic products have infiltrated the US drug supply chain, prompting the FDA and manufacturer Novo Nordisk to issue safety warnings to diabetic patients and weight loss medication users.

Key Takeaways

  • The FDA has identified counterfeit Ozempic with lot number PAR0362 and serial prefix 51746517 after products were seized on April 9, 2025.
  • Counterfeit products include fake needles that may not be sterile and could cause infections, as well as potentially harmful or ineffective medication.
  • Patients should only obtain Ozempic with valid prescriptions from state-licensed pharmacies, not through online vendors or telemedicine services offering discounts.
  • Six adverse events were reported related to lot number PAR0362, but they are not believed to be a result of the counterfeits.
  • The FDA and Novo Nordisk are testing the counterfeit products but cannot yet confirm their contents or safety profile.

FDA Alert and Identification of Counterfeits

The Food and Drug Administration has issued a warning to the American public after discovering counterfeit Ozempic (semaglutide) products have penetrated the legitimate pharmaceutical supply chain. The FDA intercepted these suspect products on April 9, 2025, after Novo Nordisk, the actual manufacturer of the diabetes and weight loss medication, identified numerous fake units.

Consumers can identify the counterfeit products by checking for specific markings. The fake Ozempic products bear labels with a legitimate lot number (PAR0362) but contain illegitimate serial numbers beginning with the prefix 51746517. The counterfeit version includes fake needles that have not undergone sterility verification, putting patients at risk of infection. Additionally, the pen label, healthcare information, and product carton have all been determined to be fraudulent, according to official FDA documentation.

Safety Risks and Ongoing Investigation

The counterfeit medications pose significant safety concerns for unsuspecting patients. Neither the FDA nor Novo Nordisk can confirm the contents, quality, or safety of these counterfeit products, which could contain incorrect dosages or potentially harmful substances. While six adverse events have been reported in relation to lot number PAR0362, none of the events appear to be a result of the counterfeits.

Dave Moore from Novo Nordisk said, “At Novo Nordisk, patient safety is our top priority, and we take the growing number of incidents involving counterfeit versions of Ozempic very seriously.” The pharmaceutical manufacturer is actively collaborating with the FDA on an ongoing investigation to determine the full scope of the counterfeit distribution and potential health impacts. Both organizations urge patients to remain vigilant about their medication sources.

Guidelines for Consumers and Healthcare Providers

Healthcare experts strongly advise patients to obtain Ozempic only through established, legitimate channels. Dr. Brett Osborn, who specializes in weight management, warned: “Due to the cost of brand-name Ozempic, more and more people are turning to cheaper knock-off versions, often found online or through non-regulated channels.” This can put patients at significant risk, as counterfeit medications lack quality assurance and safety controls.

Retail pharmacies are being directed to purchase Ozempic and other semaglutide-containing medications exclusively through authorized distributors of Novo Nordisk. The FDA also recommends that patients who suspect they may have received counterfeit products should report them immediately to both the FDA’s MedWatch Safety Information program and Novo Nordisk customer care. Maintaining the integrity of our pharmaceutical supply is a shared responsibility that requires vigilance from manufacturers, regulators, healthcare providers, and patients alike.

Sources

  1. Counterfeit Ozempic: FDA sounds the alarm, warns consumers about fake weight loss drugs
  2. FDA warns consumers not to use counterfeit Ozempic (semaglutide) found in U.S. drug supply chain
  3. Fake Ozempic drugs found in US drug supply, FDA warns