Amneal Pharmaceuticals LLC Issues Voluntary Nationwide Recall of Magnesium Sulfate in Water for Injection, USP 4 g/100mL (NDC 70121-1720-3) due to a Product Mix-up with[...]

Company Contact:

Amneal Pharmaceutical LLC
833-582-0812

FOR IMMEDIATE RELEASE - 03/24/2026 - 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 Injection, 10 mg/mL.

Risk Statement: 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.

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.

Hospitals with questions regarding this recall can contact Amneal Pharmaceuticals by:

Phone: 833-582-0812 Monday-Friday, 8:00 am-5:00 pm, EST

Fax: 631-983-2595

E-mail to: [email protected]

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.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm¹
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm² or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

The following is a picture of the products and of the carton label for Magnesium Sulfate in Water for Injection.