FDA Issues Warning About Counterfeit Ozempic Products

FDA Issues Warning About Counterfeit Ozempic Products

The FDA has seized counterfeit Ozempic drugs in the US supply chain, raising alarm for Type 2 diabetes patients who rely on the medication for blood sugar control and weight management.

Key Insights

  • The FDA seized counterfeit Ozempic products on April 9, 2025, which were distributed outside the authorized supply chain.
  • Counterfeit Ozempic can be identified by labels with lot number PAR0362 and serial numbers starting with 51746517.
  • Counterfeit components include needles with unconfirmed sterility, posing infection risks.
  • Patients should obtain Ozempic only through state-licensed pharmacies with valid prescriptions.
  • Novo Nordisk and the FDA are still testing the fake products to determine their contents and safety.

FDA Issues Public Health Alert

Federal health officials have discovered counterfeit versions of Ozempic, the popular diabetes and weight loss medication, circulating in the United States. The Food and Drug Administration announced the seizure of these fake drugs on April 14, following notification from manufacturer Novo Nordisk that numerous suspected counterfeit units had been detected. The FDA immediately launched an investigation and issued warnings to consumers, healthcare providers, and pharmacies to verify the authenticity of their Ozempic prescriptions to avoid potential health risks.

The counterfeit products were seized by federal authorities on April 9 after being distributed outside the legitimate supply chain. The FDA says no adverse events have yet been directly linked to any fake product. However, this doesn’t diminish the potential dangers these unauthorized medications pose to unsuspecting patients who depend on Ozempic to manage their Type 2 diabetes or weight.

How to Identify Counterfeit Products

Novo Nordisk has provided specific guidelines to help consumers identify the fake Ozempic pens. The counterfeits can be recognized by labels with the authentic lot number PAR0362 paired with illegitimate serial numbers starting with 51746517. Six adverse events have been reported for lot number PAR0362, but it’s not believed that they were related to the counterfeits.

Beyond the pens themselves, investigators discovered that multiple components were counterfeit, including the needles, pen labels, healthcare information materials, and packaging cartons. The non-sterile needles present a particularly concerning risk of infection for users.

Both the FDA and Novo Nordisk are conducting tests to determine the exact contents of these counterfeit products. Until these tests are complete, neither organization can confirm what substances the fake medications contain or their quality. The FDA has urged anyone in possession of suspected counterfeit Ozempic to report it immediately and discontinue use to avoid potential health complications.

Safety Recommendations and Ongoing Concerns

Medical experts emphasize that patients should only obtain Ozempic through legitimate channels. “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,” warns Dr. Brett Osborn, highlighting the economic motivations behind the counterfeit market. With authentic Ozempic often costing hundreds of dollars per month, some patients seek more affordable alternatives, unwittingly exposing themselves to dangerous substitutes.

Retail pharmacies are being advised to purchase Ozempic and other semaglutide-containing medicines exclusively through authorized distributors of Novo Nordisk. The FDA has established a reporting system for adverse events through its MedWatch Safety Information and Adverse Event Reporting Program. Patients experiencing unusual side effects after using Ozempic should contact their healthcare provider immediately and report their experience to the FDA. The agency’s investigation remains ongoing as they work to identify the source of these counterfeit drugs and prevent further distribution.

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

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