FDA Warns Online Pharmacies Selling Counterfeit Semaglutide Weight-Loss Injections After Cluster of Severe Adverse Events
The U.S. Food and Drug Administration on Wednesday warned consumers and health care providers about counterfeit semaglutide injections, including Ozempic, being sold online and seized in the United States. Officials said the fake products, distributed outside authorized channels, pose serious safety risks because their identity, quality, and effectiveness cannot be verified.
The FDA said it recently seized dozens of units of counterfeit Ozempic (semaglutide) injection 1 mg that had been distributed illegally outside Novo Nordisk’s authorized supply chain in the United States. The agency emphasized that it cannot verify the identity, quality, safety, or effectiveness of the seized counterfeit products, which may pose serious health risks to patients. Officials urged patients, wholesalers, retail pharmacies, and health care professionals not to use, distribute, or sell Ozempic products matching the identified counterfeit lot and serial numbers.
The counterfeit vials reportedly bear real lot numbers combined with illegitimate serial numbers, a key indicator of falsification, according to FDA and Novo Nordisk.
One cluster of counterfeit products carried the authentic lot number PAR0362 paired with serial numbers beginning with “51746517,” which the companies identified as illegitimate. Authorities clarified that the lot number PAR0362 alone is genuine, but any product with this lot number and serial numbers starting with “51746517” is counterfeit and unsafe. In a separate enforcement action, the FDA reported counterfeit Ozempic labeled with lot number NAR0074 and serial number 430834149057, and instructed stakeholders not to distribute, use, or sell products bearing this exact combination.
FDA and Novo Nordisk advised pharmacies and patients to carefully inspect labels, packaging, and device components, including verifying lot and serial numbers against FDA notices, as a primary method to detect suspect counterfeit semaglutide products. The agency also recommended obtaining semaglutide injections only through state-licensed pharmacies with valid prescriptions and warned against purchasing from unverified online sources.
While the FDA acknowledged receiving adverse event reports associated with the authentic lot through Novo Nordisk, officials said none of the reported events appeared directly linked to the identified counterfeit units as of the agency’s notice. However, because the contents and concentration of the counterfeit semaglutide are unknown, the FDA and Novo Nordisk warned that these products could result in ineffective treatment, under-dosing, or overdosing, all of which carry health risks, especially for patients with diabetes or obesity. Some seized counterfeit products included counterfeit needles, raising concerns about sterility and the potential for infection or transmission of blood-borne pathogens. Both the FDA and Novo Nordisk emphasized that neither entity can confirm the ingredients, sterility, or manufacturing conditions of the counterfeit injections, making any use potentially dangerous.
The FDA specifically highlighted that the seized counterfeit Ozempic entered the U.S. market outside Novo Nordisk’s authorized distribution channels, with online sellers and other unauthorized outlets identified as key concerns for counterfeit distribution. Novo Nordisk warned retail pharmacies and individuals to purchase Ozempic and other semaglutide products only through authorized distributors and cautioned that purchases from unverified online pharmacies increase the risk of receiving counterfeit products. The FDA discouraged consumers from buying prescription semaglutide without a valid prescription or at unusually low prices online, describing such offers as potential indicators of counterfeit medicines. The agency also urged reporting of suspected counterfeit or tampered medicines sold online through its criminal activity reporting channels.
The FDA is continuing its investigation into counterfeit Ozempic in the legitimate U.S. drug supply chain and has seized thousands of units as part of a broader enforcement effort. The agency is working closely with Novo Nordisk and federal partners to identify, investigate, and remove suspected counterfeit semaglutide products from the market. The investigation involves extensive visual examination and chemical testing to determine the composition, quality, and potential health risks of the seized products. The FDA said its investigation is ongoing and that it will update public safety communications as new counterfeit lots, serial numbers, or distribution channels are identified.
Novo Nordisk issued its own safety communication on April 14, 2025, confirming the distribution of “several hundred units” of counterfeit Ozempic 1 mg outside its authorized supply chain in the U.S. The company reiterated that lot number PAR0362 is authentic but stressed that products combining this lot with serial numbers starting with “51746517” are counterfeit and must not be used. Novo Nordisk advised retail pharmacies to validate their shipments using lot and serial number details and other authentication tools, and urged patients to inspect their Ozempic boxes and pens and to contact the company’s customer care line at 1-800-727-6500 or the FDA if they suspect their product may be counterfeit. The manufacturer supported the FDA’s efforts to remove counterfeit products from the supply chain due to the significant safety risks posed by unverified injections.
The FDA instructed patients, pharmacists, and clinicians to check all Ozempic 1 mg inventory for the specified counterfeit lot and serial number combinations and to quarantine any suspect products. Suspected counterfeit Novo Nordisk products can be reported directly to the FDA as suspected criminal activity through the agency’s reporting portal or local consumer complaint coordinators. Health care professionals and consumers are encouraged to report adverse events or product quality problems related to both suspected counterfeit and legitimate Ozempic products to the FDA’s MedWatch program. The FDA and Novo Nordisk also advised reporting websites selling counterfeit or tampered medicines to help enforcement efforts target illicit online operations. Patients concerned about the authenticity of their semaglutide products were directed to contact their pharmacist, prescriber, Novo Nordisk customer care, and the FDA and to stop using any product suspected to be counterfeit until its authenticity is verified.
