FDA issues its first counterfeit Ozempic alert, naming lot NAR0074

The FDA said on Dec. 21, 2023 that it was investigating counterfeit Ozempic (semaglutide) injection 1 milligram found in the legitimate U.S. drug supply chain, and that it had seized thousands of units of the product ^[1]. The agency told wholesalers, retail pharmacies, health care practitioners and patients to check what they had received and not to distribute, use or sell product labeled with lot number NAR0074 and serial number 430834149057 ^[1].

That detail — "legitimate U.S. drug supply chain" — is what set this alert apart from earlier warnings about semaglutide sold through unlicensed websites. The FDA also cautioned that some counterfeit products may still have been available for purchase at the time of the notice ^[1].

What the FDA found in the seized product

The FDA and Novo Nordisk, which makes Ozempic, said they were testing the seized products and did not yet have information about the drugs' identity, quality or safety ^[1]. In other words, what was actually inside the pens was unknown when the alert went out.

The agency did confirm several counterfeit components. Analysis found the needles from the samples were counterfeit, so their sterility could not be confirmed, which the FDA said presents an increased risk of infection for patients who use the counterfeit products ^[1]. Other confirmed counterfeit parts were the pen label, the accompanying health care professional and patient information, and the carton ^[1].

The FDA said it was aware of five adverse events from this lot, none of which were serious, and all of which were consistent with known common adverse reactions to authentic Ozempic — nausea, vomiting, diarrhea, abdominal pain and constipation ^[1].

The agency recommended that retail pharmacies buy Ozempic only through authorized distributors of Novo Nordisk and review the published photographs and information to confirm shipments are legitimate ^[1]. It said patients should obtain Ozempic only with a valid prescription through state-licensed pharmacies and check the product for signs of counterfeiting before use ^[1]. Retailers and patients with questions could contact Novo Nordisk customer care at 1-800-727-6500, Monday through Friday, 8:30 a.m. to 6 p.m. ET ^[1].

Why it matters for patients

During a period of heavy demand for semaglutide, this alert established that a counterfeit version had moved through channels that end at ordinary retail pharmacy counters, not only through gray-market online sellers ^[1]. That changes the practical question from "is this website trustworthy" to "does this specific box and pen match what the manufacturer shipped."

The needle finding is the part with a distinct safety angle. An unsterile needle carries an infection risk that is separate from whatever the pen contains ^[1]. And because testing of the seized product was still underway, the FDA could not say whether the liquid inside was semaglutide, a different drug or something else ^[1].

The five reported adverse events were not serious and looked like the usual gastrointestinal side effects of real Ozempic, which means side effects alone would not necessarily flag a fake pen for a patient ^[1]. The FDA directed consumers and health professionals to report problems through its MedWatch program, online or by fax at 1-800-FDA-0178, and to report suspected counterfeit sellers to the agency ^[1].

What happens next

The FDA said its investigation was ongoing and that it was working with Novo Nordisk to identify, investigate and remove further suspected counterfeit semaglutide injectable products found in the U.S. ^[1].

The agency later added two more entries to the same alert page. On April 14, 2025, it said Novo Nordisk had notified it on April 3, 2025 that several hundred units of counterfeit Ozempic 1 mg were in the supply chain, distributed outside the authorized channel; the FDA seized them on April 9, 2025 and flagged lot PAR0362 with serial numbers starting 51746517 ^[1]. On Dec. 5, 2025, the FDA said it had seized dozens of counterfeit units labeled PAR1229 — an authentic lot number — distinguishable by the position of the "EXP/LOT" text on the pen label ^[1]. In both later cases, six adverse event reports were tied to the lot, and the FDA said none appeared to be associated with the counterfeit product ^[1].