FDA-PR2026-03-24PACKAGING DEFECT

Amneal Magnesium Sulfate IV recalled due to wrong medication mix-up

LABEL MIX UPNationwide distribution

Stop using Amneal Magnesium Sulfate IV bags

One lot of Amneal Magnesium Sulfate in Water for Injection IV bags was found to contain the wrong medication—Tranexamic Acid—inside the packaging. This mix-up affects hospitals that received the product between late December 2025 and late February 2026. No patients have been harmed so far.

  • If you work at a hospital, check your supply of Amneal Magnesium Sulfate (Lot AH250162) and stop using it immediately.
  • Return the recalled product to Amneal Pharmaceuticals, Magnesium Sulfate Recall Coordinator, 21 Colonial Drive, Piscataway, NJ 08854.
  • Contact Amneal at 833-582-0812 (Monday–Friday, 8 a.m.–5 p.m. EST) or MagnesiumSulfateRecall@amneal.com with questions.
  • Report any adverse events to the FDA's MedWatch program at www.fda.gov/medwatch/report.htm or call 1-800-332-1088.

Product photos

Image of Magnesium Sulfate in Water for Injection, USP 4 g/100mL foil package
Image of Magnesium Sulfate in Water for Injection, USP 4 g/100mL foil package
Image of Tranexamic Acid in 0.7% Sodium Chloride Injection, 10 mg/mL IV bag
Image of Tranexamic Acid in 0.7% Sodium Chloride Injection, 10 mg/mL IV bag
Image of Magnesium Sulfate in Water for Injection, USP 4 g/100mL carton label
Image of Magnesium Sulfate in Water for Injection, USP 4 g/100mL carton label
Hazard

Bridgewater, New Jersey, Amneal Pharmaceuticals LLC is voluntarily recalling one lot of Magnesium Sulfate in Water for Injection, USP, 4g/100mL, IV bag, to the hospital level. A Magnesium Sulfate in Water for Injection pouch was found to contain an IV bag of Tranexamic Acid in 0.7% Sodium Chloride I

Official notice

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-voluntary-nationwide-recall-magnesium-sulfate-water-injection-usp

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