FDA seizes counterfeit Ozempic 1 mg pens after Novo Nordisk warning

The FDA has seized counterfeit Ozempic (semaglutide) injection 1 mg in the United States after Novo Nordisk told the agency that several hundred counterfeit units had entered the legitimate U.S. drug supply chain ^[1]. Novo Nordisk notified the FDA on April 3, 2025, and the FDA seized the products on April 9, 2025 ^[1].

The pens carry lot number PAR0362 and serial numbers beginning with the first eight digits 51746517 ^[1]. They were distributed outside Novo Nordisk's authorized supply chain in the U.S. ^[1]. Novo Nordisk says PAR0362 is an authentic lot number, and that product is counterfeit only when that lot number is combined with an illegitimate serial number ^[3].

The FDA advises patients, wholesalers, retail pharmacies and health care professionals to check the Ozempic they have received and not to use, distribute or sell product matching that lot and serial number ^[1].

What is known about the contents

FDA and Novo Nordisk are testing the seized pens and "do not yet have information about the identity, quality or safety of these drugs," the FDA said ^[1]. Novo Nordisk said: "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" ^[3]. No test results have been released, and the FDA has not given a timeline for them ^[1].

The FDA says it is aware of six adverse event reports associated with this lot, none of which appear to be associated with the counterfeit product; all six were reported by Novo Nordisk ^[1]. A news report on the same warning said the agency was aware of five adverse events tied to the lot, that none were serious, and that they were consistent with known common reactions to authentic Ozempic — nausea, vomiting, diarrhea, abdominal pain and constipation ^[3]. The two accounts disagree on the number of reports.

A news report also said analysis found the needles in the samples were counterfeit and could not be guaranteed sterile, which it said raised the risk of infection ^[3]. The FDA's notice for lot PAR0362 does not report that finding. The FDA did describe counterfeit needles and an unconfirmed sterility risk in a separate, earlier case involving counterfeit Ozempic labeled with lot number NAR0074 in December 2023 ^[1].

Why it matters for patients

Counterfeit pens that look like Ozempic can reach ordinary pharmacies, not just online sellers. The FDA describes this lot as having been in the legitimate U.S. drug supply chain, and it urges retail pharmacies to buy only through Novo Nordisk's authorized distributors ^[1]. Because the contents and sterility of the seized pens have not been established, a patient who used one would have no confirmation of what was injected or whether the needle was clean ^[1][3].

The FDA advises patients to obtain Ozempic only with a valid prescription through state-licensed pharmacies and to check the product before use ^[1]. Suspected counterfeit product can be reported to Novo Nordisk customer care at 1-800-727-6500, Monday through Friday from 8:30 a.m. to 6 p.m. ET, and to the FDA ^[1][3]. Side effects can be reported to the FDA's MedWatch program or to Novo Nordisk ^[1].

What happens next

The FDA says its investigation is ongoing and that it is working with Novo Nordisk to identify and remove further suspected counterfeit Ozempic ^[1].

Counterfeits have continued to surface. The FDA later reported that Novo Nordisk notified it on Nov. 18, 2025 that counterfeit Ozempic injection 1 mg labeled with lot PAR1229 was in the legitimate supply chain, and that the agency seized dozens of units of that product, which can be identified by the placement of the EXP/LOT text on the pen's label ^[1]. As with the April seizure, the FDA said it was aware of six adverse events for that lot, which it said were associated with authentic Ozempic and not the counterfeit product ^[1].