On Sept. 28, 2024, FDA learned that Hurricane Helene had flooded a manufacturing plant in Marion, North Carolina. The agency later described the site as "one of the largest manufacturers of intravenous and peritoneal dialysis solutions in the United States," in its annual report to Congress on drug shortages1. The plant shut down for cleanup and repair.
Within two weeks, FDA had added three more fluids to its national shortage list. Products from the plant were on allocation to hospitals, and the HHS secretary was asking providers to "implement product conservation strategies," in an Oct. 9 letter to health care leaders2.
The episode showed how few plants stand behind some of the most basic products in a hospital, and it put several federal shortage tools to work at once: temporary importation, faster reviews, extended expiration dating and relaxed compounding rules. Two years later, GxRadar's copy of FDA's data still listed six related fluids as current shortages, though most were first posted before the storm.
One plant and a national supply
IV fluids are cheap, heavy and made in bulk. Saline, dextrose and lactated Ringer's solution are used to restore fluids, to dilute other drugs and during surgery. They are also sterile injectables, the category that dominates FDA's shortage list for reasons our piece on sterile injectable shortages explains.
Writing afterward, the federal Administration for Strategic Preparedness and Response (ASPR) said that the North Carolina plant's operator produces "roughly 60% of IV fluids used in North America," in its account of the response7. ASPR called the plant "one of the nation's largest intravenous (IV) fluid manufacturing facilities." When Hurricane Milton approached Florida in early October, ASPR said it helped relocate 60 truckloads of IV fluids to keep them available.
Several of the fluids involved were already short before the storm. GxRadar's data, discussed below, show dextrose 5%, 10% and 50% injections and sterile water for injection on FDA's list since 2021 or 2022. Helene hit a market with little spare capacity, a pattern our explainer on why drug shortages happen describes.
What federal agencies did, and when
| Date | Action | Source |
|---|---|---|
| Sept. 28, 2024 | FDA learns of hurricane damage to the Marion plant | FDA report to Congress |
| Oct. 9, 2024 | HHS says FDA will speed review of shelf-life extension requests and is exploring temporary imports | HHS secretary's letter |
| Oct. 10, 2024 | HHS has declared public health emergencies for Helene in five states and for Milton in Florida | FDA guidance |
| Oct. 11, 2024 | FDA issues temporary compounding guidance; adds dextrose 70%, lactated Ringer's and peritoneal dialysis solution to shortage list | FDA roundup |
| Oct. 18, 2024 | FDA reports it has helped clear 23 IV and dialysis fluids for temporary import from five foreign facilities | FDA roundup |
| Early December 2024 | New product released from the plant "in just over 60 days" | FDA report to Congress |
| February 2025 | Plant back to pre-hurricane production levels | ASPR |
| May 2025 | Allocations removed for "virtually all" IV solution product codes from the plant | ASPR |
| Aug. 8, 2025 | FDA declares sodium chloride 0.9% shortage resolved | FDA commissioner's statement |
On Oct. 11, 2024, FDA said it now considered dextrose 70%, lactated Ringer's and peritoneal dialysis solution "to not be commercially available in adequate supply to meet national demand," according to its weekly roundup3. The same day it issued an immediately effective guidance5 letting outsourcing facilities and pharmacies compound certain parenteral products under looser conditions. The guidance said the policy was meant to last "only for the duration of the supply disruption" tied to the hurricane emergencies, or another period FDA might announce6. Our explainer on 503A and 503B compounding covers the rules it relaxed.
Imports, airlifts and the Defense Production Act
Foreign product was the largest single lever. By Oct. 18, FDA said it had acted "to conduct scientific and regulatory assessments to help facilitate the temporary importation of 23 different IV and PD fluids" from five of the same company's facilities abroad, according to that week's roundup4. FDA's later report to Congress described the legal basis. The agency "exercised enforcement discretion for temporary importation" and helped import "millions of units of product from at least four different international facilities," the report said1.
ASPR put numbers on the logistics. It coordinated 98 airlift missions carrying 13.9 million units of IV fluids, with flights arriving from October through the end of 2024. Working with FDA and the Department of Homeland Security, it said, the team cut customs processing for the shipments "from 60 days to same-day approval," according to ASPR7.
These imports did not use the state importation pathway in section 804 of the FD&C Act. That program is limited to drugs from Canada, and FDA's 2020 rule9 excludes infused and intravenously injected drugs from it. Our explainer on drug importation under section 804 covers the differences.
At home, ASPR said it used the Defense Production Act "to secure remediation materials needed to restart operations" at the plant. Production resumed in phases with 2,500 employees on round-the-clock shifts. FDA reviewed the protocols for requalifying lines before restart, covering cleaning, environmental monitoring and sterility assurance, and inspected the site after lines restarted, its report to Congress said1.
Expiration dates and the end of the saline shortage
Short-dated stock was the other pressure point. In its Oct. 9 letter, HHS said FDA would "expedite consideration of any shelf-life extension requests manufacturers submit for short-dated product." When FDA declared the saline shortage over, then-Commissioner Marty Makary listed "expedited reviews to increase manufacturing capacities and extend product expiry" among the tools used, in an Aug. 8, 2025, statement8. Our piece on drug expiration dates and shelf life explains how those extensions are justified.
That statement said the "nationwide shortage of sodium chloride 0.9% injection products" had ended and the products would come off FDA's list of current shortages. It added that FDA was still working with manufacturers on "other IV fluids still in shortage."
What FDA's shortage list shows now
GxRadar pulls FDA's shortage database from openFDA10. In the copy taken on Oct. 30, 2026, sodium chloride 0.9% injection appears only as a manufacturer's notice that three presentations are being discontinued, posted Dec. 3, 2025. Lactated Ringer's injection does not appear as a current shortage. Six related fluids do.
| Product (FDA listing) | First posted | Last updated | Reason given | Presentations |
|---|---|---|---|---|
| Amino acid injection | Dec. 8, 2020 | Oct. 19, 2026 | Shortage of an active ingredient | 16 |
| Sterile water injection | Nov. 23, 2021 | Oct. 29, 2026 | Demand increase | 13 |
| Dextrose 50% injection | Jan. 13, 2022 | Oct. 27, 2026 | Other | 4 |
| Dextrose 5% injection | Feb. 14, 2022 | Oct. 19, 2026 | Demand increase | 36 |
| Dextrose 10% injection | March 1, 2022 | Oct. 19, 2026 | Discontinuation of manufacture | 13 |
| Dextrose 70% injection | Oct. 11, 2024 | Oct. 19, 2026 | Not stated | 4 |
Source: GxRadar analysis of openFDA drug shortages data, Oct. 30, 2026. Status for all six was "Current." The full list, with charts, is on our shortage tracker.
Dextrose 70%, the one product in the table first posted the month of the storm, was still listed as a current shortage when FDA last updated its entry on Oct. 19, 2026.
Sources and notes
- FDA (2025). Report to Congress: Drug Shortages CY 2024
www.fda.gov/media/189325/download - HHS (2024). Letter to Health Care Leaders and Stakeholders on Impacts of Hurricane Helene from Secretary Becerra
www.hhs.gov/about/news/2024/10/09/letter-health-care-leaders-stakeholders-impacts-hurrican - FDA (2024). FDA Roundup: Oct. 11, 2024
www.fda.gov/news-events/press-announcements/fda-roundup-october-11-2024 - FDA (2024). FDA Roundup: Oct. 18, 2024
www.fda.gov/news-events/press-announcements/fda-roundup-october-18-2024 - FDA (2024). Temporary Policies for Compounding Certain Parenteral Drug Products, guidance page
www.fda.gov/regulatory-information/search-fda-guidance-documents/temporary-policies-compou - FDA (2024). Temporary Policies for Compounding Certain Parenteral Drug Products, guidance document (PDF)
www.fda.gov/media/182632/download - ASPR (2025). Operation Saline Shield
www.aspr.gov/readiness-response/medical-countermeasures-biodefense/ibmsc/operation-saline- - FDA (2025). Statement from FDA Commissioner announcing resolution of the IV saline solutions shortage
www.fda.gov/news-events/press-announcements/statement-fda-commissioner-marty-makary-md-mph - Federal Register (2020). Importation of Prescription Drugs, final rule, 85 FR 62094 (GovInfo)
www.govinfo.gov/content/pkg/FR-2020-10-01/pdf/2020-21522.pdf - openFDA (2026). Drug Shortages API (data as of Oct. 30, 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 assistance and checked against the sources above. Information current as of Nov 3, 2026 and may change. Spot an error? It will be corrected once confirmed.
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How drug expiration dates are setFDA's current drug shortages, by therapeutic area and dosage formPediatric drug shortagesThe 2022 contrast dye shortage, when one Shanghai plant slowed CT scans nationwideDrug importation under section 804How 503A and 503B compounding pharmacies differThe Strategic API Reserve, the federal stockpile of drug ingredientsNot 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.