Amneal Pharmaceuticals Recalls Magnesium Sulfate Due to Product Mix-Up

FDA MedWatch Safety Alerts

Filed March 24th, 2026

Detected March 25th, 2026

Summary

Amneal Pharmaceuticals LLC is voluntarily recalling one lot of Magnesium Sulfate in Water for Injection, USP, 4g/100mL, due to a product mix-up where a pouch contained an IV bag of Tranexamic Acid. The recall is to the hospital level nationwide. The company has received no adverse event reports related to this recall.

View original document View source feed page

What changed

Amneal Pharmaceuticals LLC is initiating a voluntary nationwide recall of one lot (AH250162) of Magnesium Sulfate in Water for Injection, USP, 4g/100mL, to the hospital level. The recall is prompted by the discovery that a pouch intended for Magnesium Sulfate contained an IV bag of Tranexamic Acid in 0.7% Sodium Chloride Injection. This mix-up poses a risk of delayed magnesium therapy, potentially leading to seizures in pregnant individuals with preeclampsia or eclampsia, and adverse events if Tranexamic Acid is inadvertently administered.

Hospitals are instructed to stop using the affected product and return it to Amneal Pharmaceuticals. The company is notifying distributors and hospital customers. While the likelihood of patient exposure is considered low due to hospital controls, any adverse reactions or quality problems should be reported to the FDA's MedWatch program.

What to do next

Hospitals must stop using and return recalled Magnesium Sulfate product.
Notify hospital customers of the recall.
Report adverse reactions or quality problems to FDA MedWatch.

Source document (simplified)

More Recalls, Market
Withdrawals, &
Safety Alerts

Summary

Company Announcement Date:

March 24, 2026

FDA Publish Date:

March 24, 2026

Product Type: Drugs Reason for Announcement: Recall Reason Description 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. Company Name: Amneal Pharmaceuticals LLC Brand Name: Brand Name(s) Amneal Product Description: Product Description Magnesium Sulfate in Water for Injection, USP, 4g/100mL, IV bag

Company Announcement

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: MagnesiumSulfateRecall@amneal.com

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.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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.