Importance Score: 75 / 100 🔴
The Food and Drug Administration (FDA) has issued a public alert regarding the circulation of counterfeit Ozempic within the United States.
FDA Warns of Counterfeit Ozempic Injections
In a warning released on April 14th, the FDA disclosed that Novo Nordisk, the manufacturer of both Ozempic and Wegovy, had notified the agency about the presence of “several hundred units of counterfeit Ozempic (semaglutide) injection 1 mg” in the U.S. pharmaceutical distribution network.
Ozempic and Wegovy: Intended Use
Ozempic is an injectable medication approved for the treatment of type 2 diabetes. Wegovy, containing the same active ingredient but at a higher dosage, is authorized for the treatment of obesity.
Counterfeit Products Outside Authorized Supply Chain
According to the FDA‘s announcement, “The counterfeit products were distributed outside the Novo Nordisk authorized supply chain in the US.” The agency further stated, “FDA seized the identified counterfeit products on April 9, 2025.”
Recommendations for Patients and Healthcare Providers
The FDA has urged patients, wholesalers, retail pharmacies and healthcare professionals to carefully inspect any Ozempic products in their possession.
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The agency specified that any medications bearing the lot number PAR0362 and a serial number beginning with the digits 51746517 should not be used, sold, or distributed.
Adverse Events Under Investigation
“FDA is aware of six adverse event reports associated with this lot. However, none of them appear to be associated with the counterfeit product,” the agency stated. “All six adverse events were reported by Novo Nordisk.”
Novo Nordisk Statement on Patient Safety
Dave Moore, executive vice president of US operations and President of Novo Nordisk Inc., issued a statement emphasizing patient safety:
“At Novo Nordisk, patient safety is our paramount concern, and we are taking the increasing incidents involving counterfeit versions of Ozempic with utmost seriousness,” he said.
“It is a matter of grave concern, and we are committed to alerting patients, healthcare professionals, wholesalers and retail pharmacies about counterfeit incidents as they emerge.”
Ongoing Testing and Investigation
The seized products are currently undergoing testing by both the FDA and Novo Nordisk to ascertain the identity, quality, and safety of the drugs. The FDA confirmed that its investigation remains ongoing.
Risks of Unregulated Semaglutide Products
Dr. Brett Osborn, a Florida neurosurgeon and longevity specialist who prescribes semaglutide medications, has previously cautioned against the dangers of cheaper, counterfeit versions.
“Due to the expense of brand-name Ozempic, an increasing number of individuals are turning to less expensive knock-off versions, frequently found online or through non-regulated sources,” Dr. Osborn stated.
“These imitations are produced in non-medical settings without the necessary quality assurance or quality control, making them inherently hazardous.”
Potential Harm from Unverified Medications
Dr. Osborn warned that these medications can be detrimental when their origin and production quality are not properly monitored.
“When produced in unregulated environments, there is no certainty about the contents you are injecting into your body.”
He emphasized that medications like Ozempic demand “manufacturing precision.”
“Individuals should exclusively utilize pharmaceutical-grade versions prescribed by a licensed physician,” he advised. “The risk associated with these variants is excessively high, and there are no regulations ensuring their proper production.”
Caution Advised for Online Medication Purchases
Medical professionals concur that individuals should exercise caution when ordering any medication online.
“Unless you obtain the medication from a licensed pharmacy with a valid prescription from a doctor, purchasing Ozempic or its counterfeits online is perilous,” Osborn cautioned. “You cannot verify the product’s source, ingredients, or safety.”
Importance of Legitimate Prescriptions
Osborn reiterated that medications like Ozempic should only be prescribed by a physician authorized to write prescriptions — “not a nurse practitioner via a telemedicine visit or a chiropractor.”
“When used correctly, these medications are potent tools, but can be dangerous if misused,” he concluded. “Always consult a healthcare provider with adequate training and experience in using these medications. Safety must always come first.”