FDA seizes counterfeit Ozempic lot PAR0362

The Food and Drug Administration said it seized counterfeit Ozempic (semaglutide) injection 1 mg that had reached the U.S. drug supply chain, and warned patients, pharmacies and wholesalers not to use, sell or distribute pens labeled with lot number PAR0362 and a serial number beginning with the eight digits 51746517 ^[1][3].

Novo Nordisk, which makes Ozempic, notified the FDA on April 3, 2025 that several hundred units of counterfeit product were circulating ^[1]. The fakes were distributed outside Novo Nordisk's authorized U.S. supply chain ^[1]. The FDA seized the identified counterfeit products on April 9, 2025 ^[1].

One detail matters for anyone checking a pen: lot number PAR0362 is itself a real Novo Nordisk lot number ^[3]. According to Prevention's reporting on the alert, the product is counterfeit only when that lot number is paired with an illegitimate serial number starting with 51746517 ^[3]. Counterfeiters copying a genuine lot number is a pattern the agency has seen before — in its December 2023 alert about counterfeit Ozempic labeled lot NAR0074, the FDA seized thousands of units and later found the needles in the samples were counterfeit, meaning sterility could not be confirmed and infection risk was increased ^[1].

What was and wasn't known

At the time of the April 2025 warning, the FDA said it and Novo Nordisk were testing the seized products and did not yet have information about the identity, quality or safety of the drugs ^[1]. Novo Nordisk said neither the company nor the FDA could confirm the contents or quality of the counterfeit product, which "may present a safety risk for patients who use the counterfeit product" ^[3].

The sources disagree on the number of adverse event reports. The FDA's alert page states the agency was aware of six adverse event reports associated with this lot, that none of them appeared to be associated with the counterfeit product, and that all six were reported by Novo Nordisk ^[1]. Prevention reported five adverse events tied to the counterfeit lot, none of them serious and all consistent with known common reactions to authentic Ozempic — nausea, vomiting, diarrhea, abdominal pain and constipation ^[3]. That five-event description matches the language the FDA used in its earlier December 2023 alert about a different lot ^[1]. The FDA page as currently posted says six.

The FDA told retail pharmacies to buy Ozempic only through Novo Nordisk's authorized distributors and to review shipment information to confirm legitimacy ^[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]. Pharmacists and patients with questions can reach Novo Nordisk customer care at 1-800-727-6500, Monday through Friday, 8:30 a.m. to 6 p.m. ET ^[1][3]. Suspected problems can be reported to the FDA's MedWatch program ^[1].

Why it matters for patients

Ozempic is a once-weekly injection approved in December 2017 for type 2 diabetes, with later approvals to reduce cardiovascular risk and the risk of worsening kidney disease in people with type 2 diabetes ^[2]. The 1 mg dose involved here comes from the 4 mg/3 mL pen ^[2].

The practical issue is that counterfeits in this case were found inside the legitimate supply chain, not just on gray-market websites. That means a pen dispensed by a pharmacy could, in rare cases, carry a real-looking lot number. The FDA's guidance is to check the printed lot and serial numbers against the affected combination ^[1][3]. Because testing was still underway when the alert posted, what these pens actually contained — whether any semaglutide, and in what amount — is not established in these sources.

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 injectables in the U.S. ^[1]. The problem did not end in April. On December 5, 2025, the FDA posted a new alert saying it had seized dozens of units of counterfeit Ozempic 1 mg labeled with lot number PAR1229 — again a real lot number — after Novo Nordisk notified the agency on November 18, 2025 ^[1]. In that case, the counterfeit can be spotted because the "EXP/LOT" text sits to the left of the expiration date and lot number, instead of above it ^[1].