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FDA Sounds Alarm on ‘Counterfeit’ Ozempic—What to Know

Last updated: April 24, 2025 8:00 pm
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FDA Sounds Alarm on ‘Counterfeit’ Ozempic—What to Know
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  • The U.S. Food and Drug Administration (FDA) and drug manufacturer Novo Nordisk are warning consumers about “counterfeit” Ozempic found outside the authorized drug supply chain.

  • The contents of the counterfeit drugs have yet to be determined, but potentially unsterile needles may pose a risk of infection.

  • Here’s how to tell if you may have counterfeit Ozempic and what to do.


Amid the various drug and food recalls this year, the U.S. Food and Drug Administration (FDA) has made another announcement that may affect many consumers taking the popular type 2 diabetes drug, Ozempic.

The FDA and Novo Nordisk (the manufacturer of Ozempic) issued press releases early last week regarding several hundred units of “counterfeit” Ozempic injection 1 mg found and distributed outside the authorized drug supply chain throughout the United States. The FDA noted in their press release that the “U.S. FDA seized the identified counterfeit products” on April 9, 2025.

However, the FDA urges patients, healthcare professionals, pharmacies, and wholesalers to confirm that the Ozempic products in their possession are legitimate and to avoid using, selling, or distributing affected products.

The affected Ozempic injection 1 mg feature lot number PAR0362 and illegitimate serial numbers beginning with the first eight digits 51746517. Lot number PAR0362 is authentic, authorities confirm, and is only counterfeit if combined with an illegitimate serial number.

The affected products contain counterfeit visual features. “Neither Novo Nordisk nor FDA can confirm the contents or quality of the counterfeit product, which may present a safety risk for patients who use the counterfeit product,” Novo Nordisk explained in a press release.

Further investigation into the contents of the products is underway, but analysis found that “needles from the samples are counterfeit” and cannot be guaranteed to be sterile, meaning that use of the counterfeit product poses an increased risk of infection, per the FDA.

The FDA stated that the agency is aware of five “adverse events” related to the counterfeit lot. However, none of the events were “serious” and have been “consistent with known common adverse reactions to authentic Ozempic, which are nausea, vomiting, diarrhea, abdominal pain, and constipation.”

If you believe you may possess counterfeit Ozempic, Novo Nordisk encourages you to report the product by calling their customer care team at 1-800-727-6500 (8:30 a.m. to 6:00 p.m. EST, Monday through Friday) and to report it directly to the FDA here.

If you experience any side effects, report them to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program as well as to Novo Nordisk, using the same customer care number above.

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