A Statement from FDA Commissioner Marty Makary, M.D., M.P.H: Announcing Resolution of the IV Saline Solutions Shortage

For Immediate Release:: August 08, 2025
Statement From:: Martin A Makary, M.D., M.P.H.
Commissioner of Food and Drugs - Food and Drug Administration

I am pleased to announce that the nationwide shortage of sodium chloride 0.9% injection products, a form of intravenous (IV) saline, has officially ended. This marks a significant milestone for public health and reinforces the FDA’s commitment to ensuring Americans have consistent access to life-saving medical products.

This success is the result of close collaboration between the FDA, the Administration for Strategic Preparedness and Response, and our industry partners, who worked swiftly and strategically to expand manufacturing capacity and restore stability to the supply chain. Their responsiveness and innovation have been vital to this achievement. In addition, the FDA used its available regulatory tools to help increase supplies available to hospitals to help meet patient needs. For example, the FDA conducted scientific and regulatory assessments to help facilitate the temporary importation of intravenous solutions and expedited reviews to increase manufacturing capacities and extend product expiry.

The shortage of sodium chloride 0.9% injection products has resolved, and therefore these products will be removed from the FDA list of Current Shortages in the Drug Shortage Database on the FDA website. We generally recommend hospitals, health systems, and clinics use the FDA-approved drug when available.

For other IV fluids still in shortage, the FDA is working closely with manufacturers and will continue to monitor the supply to help ensure patients have access to the medicines they need. The availability of reliable medical products is essential to patient care and the overall resilience of our healthcare system. Addressing this shortage has been a top priority for the FDA and aligns with the Trump Administration’s broader commitment to strengthening the U.S. drug and medical supply chain.

The FDA remains focused on doing all we can to help mitigate shortages and prevent them from occurring. We will continue working diligently to monitor supply levels, anticipate potential disruptions, and support a robust, secure, and transparent supply chain for medical products.

###

Boilerplate

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.