FDA, Novo Nordisk Investigating Counterfeit Semaglutide Injection in US Supply Chain

©Natalia/AdobeStock

Several hundred counterfeit units of semaglutide (Ozempic^®) injection 1 mg have been identified in the US, prompting a joint investigation by the US FDA and manufacturer Novo Nordisk. Health care professionals are advised to exercise caution and verify products to prevent patient exposure to potentially unsafe medication.^1,2

Novo Nordisk notified the FDA of the issue on April 3, 2025, and the FDA seized the affected products on April 9, 2025.¹ The counterfeit product bears the authentic lot number PAR0362 and illegitimate serial numbers beginning with 51746517. The lot number alone is not indicative of counterfeiting; the combination of the lot number with these serial digits is key for identification.^1,2

Although 6 adverse events have been reported in connection with lot PAR0362, none appear linked to the counterfeit product at this time. All 6 reports were submitted by Novo Nordisk.¹ However, both FDA and Novo Nordisk have emphasized that the contents and safety profile of the counterfeit units remain unknown, as laboratory testing and analysis are ongoing.^1,2

Clinicians should remain alert for signs that patients may have inadvertently received counterfeit medication, particularly if the product appears visually altered, was obtained through a nontraditional source, or is not producing expected clinical effects. Physicians are encouraged to counsel patients to check packaging details and to confirm their pharmacy sources use authorized Novo Nordisk distributors, the company stated in a press release today.²

Verification and Reporting

Health care professionals and pharmacists should:

• Inspect semaglutide injection 1 mg inventory for products labeled with lot PAR0362 and serial numbers beginning with 51746517.^1,2
• Stop distribution or sale of any identified counterfeit units.¹
• Instruct patients not to use products that match the counterfeit description.²

Suspected counterfeit products and adverse reactions should be reported to:

• Novo Nordisk Customer Care: 1-800-727-6500 (Monday–Friday, 8:30 AM to 6:00 PM EST)
• FDA MedWatch: www.fda.gov/medwatch or 1-800-FDA-1088
• FDA Counterfeit Reporting: Report Suspected Criminal Activity

References:

1. US Food and Drug Administration. FDA warns consumers not to use counterfeit Ozempic (semaglutide) found in U.S. drug supply chain. Updated April 14, 2025. Accessed April 14, 2025. https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-use-counterfeit-ozempic-semaglutide-found-us-drug-supply-chain
2. Novo Nordisk warns consumers about counterfeit Ozempic® (semaglutide) injection 1 mg in the US. News release. Novo Nordisk. April 14, 2025. Accessed April 14, 2025. https://www.novonordisk-us.com/media/news-archive/news-details.html?id=915970