Fluorouracil Shortage: What Providers and Prescribers Need to Know in 2026

Fluorouracil (5-fluorouracil, 5-FU) has been listed as a current drug shortage by ASHP since January 2023. As of early 2026, the shortage remains active, with multiple manufacturers — Accord, Alembic, Eugia US, and Xiromed — experiencing supply constraints. Fresenius Kabi and Sagent continue to maintain available supply, but constrained distribution means shortages are felt unevenly across regions, practice settings, and pharmacy types.

This clinical overview is designed to help oncologists, hematologists, dermatologists, radiation oncologists, and their pharmacy teams navigate the shortage, manage patients proactively, and make evidence-based decisions when alternative approaches are necessary.

Current Shortage Status and Manufacturer Landscape

As of the most recent ASHP update (January 4, 2026), the fluorouracil injection shortage status is as follows:

Accord Healthcare: Shortage due to manufacturing delays. 100 mL vials (NDC 62332-0779-31, NDC 62332-0751-50) on back order; short-dated 10 mL/20 mL vials expiring June 2026 may be available.

Alembic Pharmaceuticals: On shortage. No stated reason. 50 mL and 100 mL vials affected.

Eugia US: On shortage. No stated reason. 50 mL vials affected.

Xiromed: On shortage. No stated reason.

Fresenius Kabi: Available. 10 mL (NDC 63323-0117-10), 20 mL (NDC 63323-0117-20), and 100 mL (NDC 63323-0117-61) vials at 50 mg/mL.

Sagent Pharmaceuticals: Available.

Clinical Impact by Indication

Fluorouracil is a critical component of multiple FDA-approved oncology regimens. The following indications are most directly affected by the shortage:

Colorectal cancer: FOLFOX (5-FU/leucovorin/oxaliplatin) and FOLFIRI (5-FU/leucovorin/irinotecan) are first-line standards. Treatment delays directly impact patient outcomes.

Gastric/GEJ adenocarcinoma: FLOT (5-FU/leucovorin/oxaliplatin/docetaxel) is the perioperative standard.

Pancreatic cancer: FOLFIRINOX and mFOLFIRINOX use fluorouracil as a key component.

Breast cancer: CMF (cyclophosphamide/methotrexate/5-FU) and other regimens in specific patient subsets.

Head and neck cancers: TPF (docetaxel/cisplatin/5-FU) and concurrent chemoradiation regimens.

Evidence-Based Alternative Strategies

The primary pharmacologic alternative to IV 5-FU is capecitabine (Xeloda), an oral fluoropyrimidine prodrug. FOLFOX to CAPOX (capecitabine plus oxaliplatin) and FOLFIRI to XELIRI substitutions have been supported by phase III equivalence data for colorectal cancer. Key considerations:

CAPOX has equivalent efficacy to FOLFOX-4 based on randomized phase III data (XELOX trials).

Capecitabine has greater hand-foot syndrome incidence vs. infusional 5-FU; less neutropenia and venous thrombotic events.

Warfarin interactions are clinically significant with capecitabine due to the intermittent dosing schedule — INR monitoring must be increased.

DPD/DPYD testing is equally critical for capecitabine as for IV 5-FU — identical fluoropyrimidine toxicity risk.

DPYD Testing: Updated 2026 FDA Labeling

In February 2026, the FDA released updated safety labeling for both 5-FU and capecitabine to increase awareness of DPD deficiency and DPYD gene variants. The FDA now recommends considering DPYD genotyping prior to initiating treatment. Patients with certain DPYD variants (particularly DPYD*2A and DPYD*13) are at risk for severe or fatal toxicity and require dose reduction or alternative regimen selection. Complete DPD deficiency affects an estimated 0.2% of individuals; partial deficiency is considerably more common.

Pharmacy Management Recommendations

Contact multiple distributors — particularly Fresenius Kabi and Sagent — directly for available NDCs.

Consider short-dated vials (expiration June 2026) from Accord for patients with imminent treatment needs.

Establish or update shortage protocols: prioritize patients on active curative-intent treatment over adjuvant or palliative settings where short delays are less harmful.

Document shortage-related supply chain decisions in the medical record.

Patient Communication Guidance

Patients are often discovering the shortage themselves and coming to appointments with concerns. Proactive communication reduces anxiety and prevents last-minute treatment disruptions. Consider directing patients to tools that help locate available pharmacies. medfinder for providers is designed to help practices assist patients in locating medications at pharmacies near them.

For a more detailed clinical operational guide, see our provider's guide to helping patients find fluorouracil.