Amneal Pharmaceuticals has announced a voluntary nationwide recall of one lot of Magnesium Sulfate in Water for Injection, USP, 4 g/100 mL IV bags, after a product pouch labeled for magnesium sulfate was found to contain an IV bag of tranexamic acid in 0.7% sodium chloride injection, 10 mg/mL. The recall, initiated March 24, 2026, affects lot AH250162 (NDC 70121-1720-3), supplied in cartons of twelve 100 mL pouches and distributed to wholesalers and distributors across the United States between December 22, 2025 and February 27, 2026.
Magnesium sulfate injection is indicated for the prevention and control of seizures in patients with preeclampsia and eclampsia, and delays in therapy could result in life-threatening or long-term morbidity in pregnant individuals and preterm neonates, according to the company’s risk statement. If tranexamic acid is inadvertently administered instead, patients may face risks including blood clotting, seizures, hypersensitivity reactions, visual disturbances, and dizziness. Amneal reported that no adverse events related to this issue have been received to date.
The company noted that the likelihood of the mix-up reaching patients is considered low because hospital medication-use systems include multiple verification steps, and the tranexamic acid IV bags are clearly labeled and barcoded. Amneal has inspected 74% of magnesium sulfate pouches remaining in its possession and found no additional mix-ups. The firm is notifying distributors and asking hospitals to stop using and return affected product to the company. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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