FDA Sounds the Alarm on Fake Ozempic Products

FDA Sounds the Alarm on Fake Ozempic Products

The FDA has issued a warning about counterfeit Ozempic drugs found in the US supply chain, raising concerns for the millions of Americans who rely on this medication for type 2 diabetes management.

Quick Takes

  • Counterfeit Ozempic found in the US drug supply can be identified by lot number PAR0362 and serial numbers starting with 51746517.
  • The FDA seized the counterfeit products on April 9, 2025 after Novo Nordisk reported their existence.
  • Counterfeit needles pose infection risks due to unconfirmed sterility.
  • Patients should only obtain Ozempic through state-licensed pharmacies with valid prescriptions.
  • While six adverse events associated with lot number PAR0362 have been reported, none have been linked to the counterfeit products.

Warning Issued

The Food and Drug Administration has announced the discovery of counterfeit Ozempic pens circulating in the US pharmaceutical supply chain. The warning comes after Novo Nordisk, the legitimate manufacturer of the popular diabetes and weight loss medication, reported finding unauthorized products. The FDA subsequently seized the counterfeit drugs on April 9, 2025. Authorities are currently testing the seized products but cannot yet confirm their contents or safety profile.

Dave Moore from Novo Nordisk addressed the situation, saying, “At Novo Nordisk, patient safety is our top priority, and we take the growing number of incidents involving counterfeit versions of Ozempic very seriously.” Both Novo Nordisk and the FDA are actively collaborating to alert healthcare providers, pharmacies, and patients about the potential danger these counterfeit products present.

How to Identify Counterfeit Products

The FDA has provided specific guidance to help consumers identify the counterfeit Ozempic products. The fake pens can be recognized by a label showing lot number PAR0362 with serial numbers beginning with 51746517. Multiple components of the counterfeit products raise safety concerns, including the pen labels, healthcare information, packaging cartons, and most alarmingly, the injection needles. The FDA specifically warns that these counterfeit needles cannot be confirmed as sterile, potentially exposing users to infection risks.

While six adverse events have been reported relating to lot number PAR0362, none of those cases have been specifically linked to counterfeit products. Patients who suspect they have a counterfeit product should immediately contact their healthcare provider and report it to both the FDA and Novo Nordisk customer care.

Dangers of Unregulated Medications

Healthcare experts are warning consumers about the significant risks associated with obtaining Ozempic through unauthorized channels. Dr. Brett Osborn, a medical expert quoted by Fox News, cautions that the high cost of brand-name Ozempic has driven many to seek cheaper alternatives. “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,” Dr. Osborn explains.

The North Carolina Attorney General has also issued warnings about fake weight loss drugs, though they report no cases in their state to date. Medical experts stress that medications like Ozempic should only be prescribed by licensed physicians and obtained through legitimate pharmacies. Patients should be particularly vigilant about offers that seem too good to be true, as counterfeit medications typically lack quality assurance standards and can contain harmful ingredients or improper dosages of active compounds.

Protecting Yourself from Counterfeit Medications

The FDA is advising consumers to take several precautionary steps to protect themselves. First, patients should only obtain Ozempic with a valid prescription from state-licensed pharmacies. When receiving medication, carefully inspect the packaging, labels, and the medication itself for any signs of tampering or unusual appearance. If you notice anything suspicious, contact your pharmacy immediately. Retail pharmacies are being instructed to purchase semaglutide-containing medications exclusively through authorized Novo Nordisk distributors.

The FDA’s investigation into the counterfeit drugs remains ongoing, with authorities working to determine the source and extent of distribution. Patients experiencing adverse effects should report them to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. With the prevalence of weight loss medications continuing to grow, vigilance against counterfeits becomes increasingly important for consumer safety in the pharmaceutical marketplace.

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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