According to the U.S. Food and Drug Administration (FDA), the recall was triggered after “a Magnesium Sulfate in Water for Injection pouch was found to contain an IV bag of Tranexamic Acid,” a different drug that is used to control bleeding.
The affected product, lot AH250162, was distributed nationwide to wholesalers and hospitals between Dec. 22, 2025, and Feb. 27, 2026, and is being recalled at the hospital level.
According to the recall, the affected lot was packaged in 12 pouches of 100 milliliters per carton, but does not specify the total number of IV bags recalled.
NTD contacted Amneal Pharmaceuticals for comment, but a company spokesperson was not available.
Preeclampsia is a serious blood pressure disorder that develops after 20 weeks of pregnancy or postpartum. It is marked by high blood pressure and signs of organ damage.
Preeclampsia requires close monitoring to prevent severe, life-threatening complications for both mother and baby. Eclampsia represents the most severe progression of preeclampsia and can cause life-threatening seizures or coma.
Magnesium sulfate is considered a critical treatment for preventing life-threatening seizures in patients with preeclampsia and eclampsia.
“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,” warned Amneal.
The company also warned that delays in receiving the correct medication in preterm pregnant individuals could result in “life-threatening or long-term morbidity,” particularly for premature infants.
Tranexamic acid, the unintended drug in the mix-up, works differently in the body and is not a substitute for magnesium sulfate. Tranexamic acid in 0.7 percent sodium chloride injection is prescribed for patients with hemophilia for short-term use to reduce or prevent bleeding and during tooth extraction procedures.
Amneal warned that if tranexamic acid is mistakenly given instead of magnesium sulfate, "it could result in adverse events, including blood clotting, seizures, hypersensitivity reactions, visual disturbances, and dizziness."
Amneal has not received any adverse event reports related to this recall, it stated.
“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,” stated the company’s recall.
Amneal said it is notifying distributors by UPS and asking them to notify hospitals about the recall.
Patients currently receiving treatment who have concerns about their medications should consult their healthcare providers.
The FDA said adverse reactions or quality issues can be reported through its MedWatch Safety Information and Adverse Event Reporting Program.