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 Injection, 10 mg/mL.

There is a reasonable probability that delay in receiving magnesium therapy could result in life-threatening or long-term morbidity in pregnant individuals with preeclampsia or eclampsia due to the potential to develop seizures. Additionally, delay in receiving magnesium therapy in preterm pregnant individuals could result in long-term morbidity for the preterm neonate due to complications of prematurity. Amneal has not received any adverse event reports related to this recall. If Tranexamic Acid (TXA) is inadvertently administered it could result in adverse events, including blood clotting, seizures, hypersensitivity reactions, visual disturbances, and dizziness.

Magnesium Sulfate in Water for Injection (NDC 70121-1720-3) is indicated for the prevention and control of seizures in preeclampsia and eclampsia. Lot AH250162, is packaged 12 x 100mL pouches to a carton and was distributed nationwide to wholesalers/distributors between 12/22/2025 and 2/27/2026.

Magnesium Sulfate Recall Photo courtesy: Food and Drug Administration

Tranexamic acid in 0.7% sodium chloride injection is indicated in patients with hemophilia for short-term use to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.

The likelihood of such a mix-up reaching a patient is considered low as hospital medication-administration controls provide multiple safety checks prior to administration. Amneal conducted a thorough examination of 74% of the Magnesium Sulfate pouches that remain in our possession. No product mix issue was identified in this inspection. Additionally, each Tranexamic Acid IV bag is clearly labeled with the product name and includes a readable bar code, making incorrect identification readily detectable.

Amneal is notifying distributors by UPS and is asking for distributors to notify their hospital customers of the product recall. Hospitals that have Magnesium Sulfate in Water for Injection which is being recalled should stop using and return the product to Amneal. Product should be returned to Amneal Pharmaceuticals, Magnesium Sulfate Recall Coordinator, 21 Colonial Drive, Piscataway, NJ 08854.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

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