Hurricane Maria came ashore near Yabucoa, on Puerto Rico's southeast coast, around 6:15 a.m. local time on September 20, 2017. It knocked down 80 percent of the island's utility poles and all of its transmission lines, leaving essentially all 3.4 million residents without power, according to the National Hurricane Center's report on the storm1.
Five weeks later, FDA's commissioner told Congress that about 8 percent of the medicines Americans consume, measured by dollar value, were made on the island. FDA was watching about 40 critical products made solely or mainly in Puerto Rico, 14 of them with no alternative source, and had surveyed plants and found none running above 70 percent of normal output, according to the agency's October 24, 2017, testimony3.
Seven years later, Hurricane Helene exposed the same weakness on the mainland when floodwater shut a North Carolina plant that ranks among the country's largest makers of IV fluids. The two storms bracket most of what federal agencies have learned about disasters and drug supply. This piece traces both from FDA, NOAA and HHS records, the law Congress passed in between, and what FDA's own hazard mapping and shortage list show now.
Puerto Rico's plants on generator power
FDA's 2017 testimony laid out the scale. About 50 firms made drug products in Puerto Rico and about 40 made devices, and roughly 80 percent of the drug products made there were consumed in Puerto Rico and the 50 states. FDA had identified about 9,000 medical product firms in the path of that season's storms for follow-up and had called about 5,000 of them.
Damage to buildings was only part of it. Most plants had restarted, the testimony said, but they were running on generators, many of them old and never meant to run for weeks, and many firms needed help securing fuel. Reports of output below 50 percent were common, and many firms were at about 20 percent. If a plant shut down, restarting could be slow, the testimony warned, because a facility usually needs to be reinspected and batches in storage depend on continuous air handling and refrigeration. FDA also flagged the availability of secondary supplies, such as the medical gases used in production.
Power was slow to return. By the end of 2017, nearly half of Puerto Rico's residents were still without electricity, and by the end of January 2018 about 65 percent of the island had it back, the hurricane center reported.
IV saline, the shortage Maria made worse
The product that drew the most attention was sterile saline, the basic IV fluid. In its report to Congress on 2017 drug shortages4, FDA said saline "has been intermittently in shortage for several years as manufacturing capacity has worked to keep up with demand," and that Maria disrupted production at a Puerto Rico plant, making the shortage worse. The report said Hurricanes Harvey and Irma also caused disruptions that fall.
FDA's main tool was temporary importation. It did not object to imports of saline not approved for the US from one company's plants in Ireland, Australia, Mexico, Canada and Brazil and from another company's plant in Germany, the report said, and it expedited applications from additional saline makers, approving two in 2017. The October testimony said FDA had used such imports to address shortages on 37 occasions in the previous seven years, and that "in most cases, overseas firms cannot fully meet U.S. needs." Our explainer on temporary importation during shortages covers how FDA screens those products.
Risk management plans, from proposal to law
FDA's 2019 report on the root causes of drug shortages5 used Maria as its example of a natural-disaster shortage, one where a drug was not already short until a storm "damaged the power grid" and forced plants to stop. It also backed a legislative proposal in the president's fiscal 2020 budget to require application holders of certain critical drugs to assess vulnerabilities in their supply chains and plan for them. Many applicants lacked such plans, the report said, "putting them at risk for drug supply disruptions following disasters (e.g., hurricanes)."
Congress acted in March 2020. Section 3112(b) of the CARES Act added section 506C(j) to the Federal Food, Drug, and Cosmetic Act, which requires certain manufacturers to maintain "a redundancy risk management plan" covering each establishment that makes the drug or its active ingredient, as FDA's fiscal 2023 quality report6 notes. Our piece on the CARES Act and drug shortage reporting covers the law's other provisions.
Helene and the North Carolina plant
Helene made landfall in Florida's Big Bend as a Category 4 hurricane late on September 26, 2024, and then dumped catastrophic rain on the southern Appalachians. In the western half of McDowell County, North Carolina, 15 to 22 inches fell, and the Catawba River near Pleasant Gardens topped its record level by more than 4 feet, according to the hurricane center's report2. The storm killed at least 250 people in the US, the deadliest in the contiguous states since Katrina in 2005.
On September 28, FDA learned the storm had hit a plant in Marion, the McDowell County seat, that the agency later called "one of the largest manufacturers of intravenous and peritoneal dialysis solutions in the United States," in its report to Congress on 2024 shortages7. ASPR put the operator's share at "roughly 60% of IV fluids used in North America," in its account of the federal response10.
FDA moved within two weeks. On October 11, it added dextrose 70 percent, lactated Ringer's and peritoneal dialysis solution to its shortage list and issued temporary compounding guidance, according to its roundup that day8. A week later it said it had cleared 23 IV and dialysis fluids for temporary import from five of the company's foreign facilities, per the October 18 roundup9. ASPR coordinated 98 airlift missions carrying 13.9 million units and helped relocate 60 truckloads of IV fluids ahead of Hurricane Milton. New product left the plant in just over 60 days, FDA said, and ASPR said output reached pre-hurricane levels by February 2025. FDA declared the saline shortage over11 on August 8, 2025. Our full account of the 2024 IV fluid shortage has the week-by-week timeline.
| Hurricane Maria, 2017 | Hurricane Helene, 2024 | |
|---|---|---|
| Landfall | Near Yabucoa, Puerto Rico, about 1015 UTC on September 20, as a high-end Category 4 | Florida's Big Bend, about 0310 UTC on September 27 (late September 26 local time), as a Category 4 |
| Deaths | 2,975 in Puerto Rico, direct and indirect, by the Puerto Rico government's estimate | At least 250 in the US, including at least 175 direct |
| Damage estimate | $90 billion in Puerto Rico and the US Virgin Islands | $78.7 billion in the US |
| Power | Lost by essentially all 3.4 million Puerto Rico residents | Lost by about 7.4 million customers |
| Effect on drug supply | Plants on generators; about 40 critical products monitored, 14 of them sole-source; existing IV saline shortage worsened | One of the largest US makers of IV and dialysis solutions shut; three fluids added to FDA's shortage list on October 11 |
| Temporary imports | Saline from plants in Ireland, Australia, Mexico, Canada, Brazil and Germany | 23 IV and dialysis fluid products from five foreign facilities |
| Recovery milestones | In October 2017, FDA found no surveyed firm above 70 percent of normal output | New product released in just over 60 days; pre-storm output by February 2025; saline shortage declared over August 8, 2025 |
Sources: National Hurricane Center tropical cyclone reports for Maria1 and Helene2; FDA testimony (2017); FDA reports to Congress on drug shortages for 2017 and 2024; FDA roundups of October 11 and 18, 2024; ASPR.
Where FDA says the risk sits
In its fiscal 2023 quality report, FDA mapped the 575 sites in the contiguous US that make drugs on its essential medicines list against FEMA's National Risk Index, which rates counties on 18 natural hazards. Thirty-four percent of the sites were in counties rated relatively high or very high risk.
| FEMA National Risk Index rating of the county | Essential-medicine sites | Share |
|---|---|---|
| Very low | 26 | 5% |
| Relatively low | 92 | 16% |
| Relatively moderate | 258 | 45% |
| Relatively high | 134 | 23% |
| Very high | 65 | 11% |
| Total | 575 | 100% |
Source: FDA FY2023 Report on the State of Pharmaceutical Quality6, Table 3. The count excludes the 20 essential-medicine sites in Puerto Rico.
FDA said the high-risk counties sit mainly along the Pacific coast, the Gulf of Mexico and the southern Atlantic, with hurricanes and lightning driving the risk on the Gulf and southern Atlantic coasts, and that "many of the higher risk counties in California and Florida are home to multiple EM manufacturers." The plant Helene flooded sat in the mountains of western North Carolina, far from the coasts FDA flagged. Our explainers on sterile injectable shortages and how hospitals manage shortages explain why fluids made at a few plants leave so little slack, and where FDA's registered drug factories are maps the wider network.
Two years after Helene, the shortage list still carries the aftermath. In GxRadar's copy of FDA's shortage data12 from November 3, 2026, dextrose 70 percent injection, first posted on October 11, 2024, remains a current shortage. Dextrose 5, 10 and 50 percent injections and sterile water for injection, all listed since 2021 or 2022, are current too, while sodium chloride 0.9 percent appears only as a December 3, 2025, notice that three presentations are being discontinued. Our shortage tracker shows the full list, and what to ask when the pharmacy has a back order covers the questions to put to a pharmacist when a product is short.
Sources and notes
- NOAA National Hurricane Center (2018, revised 2023). Tropical Cyclone Report: Hurricane Maria
www.nhc.noaa.gov/data/tcr/AL152017_Maria.pdf - NOAA National Hurricane Center (2025). Tropical Cyclone Report: Hurricane Helene
www.nhc.noaa.gov/data/tcr/AL092024_Helene.pdf - FDA (2017). Examining HHS' Public Health Preparedness for and Response to the 2017 Hurricane Season, testimony, October 24, 2017
www.fda.gov/news-events/testimony/examining-hhs-public-health-preparedness-and-response-20 - FDA (2018). Report on Drug Shortages for Calendar Year 2017
www.fda.gov/media/113991/download?attachment - FDA (2019). Drug Shortages: Root Causes and Potential Solutions
www.fda.gov/media/131130/download?attachment - FDA (2024). Fiscal Year 2023 Report on the State of Pharmaceutical Quality
www.fda.gov/media/179254/download?attachment - FDA (2025). Drug Shortages: CY 2024, report to Congress
www.fda.gov/media/189325/download?attachment - FDA (2024). FDA Roundup: October 11, 2024
www.fda.gov/news-events/press-announcements/fda-roundup-october-11-2024 - FDA (2024). FDA Roundup: October 18, 2024
www.fda.gov/news-events/press-announcements/fda-roundup-october-18-2024 - ASPR (2025). Operation Saline Shield
www.aspr.gov/readiness-response/medical-countermeasures-biodefense/ibmsc/operation-saline- - FDA (2025). Statement announcing resolution of the IV saline solutions shortage
www.fda.gov/news-events/press-announcements/statement-fda-commissioner-marty-makary-md-mph - openFDA. Drug Shortages API (data as of November 3, 2026)
open.fda.gov/apis/drug/drugshortages/
Superscript numbers in the text link to these sources. GxRadar data (NADAC histories, recall and shortage counts) come from CMS and FDA files described on the sources page. Researched and drafted with AI tools from the sources above and checked with automated and AI-assisted review; not individually reviewed by a pharmacist or physician. Information current as of Nov 3, 2026 and may change. Spot an error? Report it and it will be corrected once confirmed.
Not health advice. GxRadar is for general information only. Nothing here is medical, pharmacy, legal or financial advice. Do not start, stop or change any medicine based on this site. Talk to your pharmacist or prescriber about your own situation. Laws, prices and program rules described here can change; confirm current details with the official source.