Last update on 17 August 2026.
Sanofi's Waterford, Ireland manufacturing facility received an FDA Warning Letter on June 23, 2026. Actions Sanofi is taking in response have contributed to shipment delays for several products in some markets. Every batch released from Waterford continues to meet all established requirements including identity, strength, quality, and purity.
The impact varies by country and by product, depending on available inventory, local demand and the timing of upcoming shipments. In some markets, delays are limited; in others, intermittent or recurring supply interruptions have reached patients or may do so as the situation evolves.
As we work to resolve the delays, we are coordinating with country affiliates to manage available supply, minimize patient impact, and support continuity of care wherever possible. At the same time, we are communicating with regulatory authorities in accordance with local reporting requirements. We will continue to provide updates as new information becomes available.
Healthcare providers should reach out to their Sanofi representative if they have any questions about the availability of affected products.
Patients may have questions or concerns about what this situation could mean for their treatment. Patients should speak directly with their treating healthcare professional, who can provide guidance based on their individual medical needs.