Ongoing FDAEvent 98587Company announced Mar 24, 2026 (6 months ago)

Amneal Pharmaceuticals Magnesium Sulfate in Water for Injection

Magnesium Sulfate in Water for Injection IV bags may contain Tranexamic Acid instead, which can cause blood clotting, seizures, and other adverse events.

High risk

There is a reasonable chance that taking it could cause serious health problems or death.

FDA Class I recall · How risk is rated

4 photos

What to do

Amneal Pharmaceuticals, LLC, of Bridgewater, New Jersey, is recalling Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bags, packaged in cartons of 12 x 100 mL IV bags, after a foil pouch labeled for that product was found to contain an IV bag of Tranexamic Acid in 0.7% Sodium Chloride Injection, 10 mg/mL. The recall began on March 18, 2026, and was announced on March 24, 2026.

The recalled product, manufactured by Amneal Pharmaceuticals Pvt. Ltd. in Ahmedabad, India, and distributed by Amneal Pharmaceuticals LLC, was distributed nationwide in the U.S.A. The recall involves 784 cartons. The FDA added the recall to its Enforcement Report on April 1, 2026, and it was in the weekly enforcement report on April 8, 2026. The FDA classified the recall on April 13, 2026.

Summary by Recall Canary from the FDA notice.

More labeling error recalls

What to do

If a code on your package matches:

Hospitals that have Magnesium Sulfate in Water for Injection which is being recalled should stop using.
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, ESTFax: 631-983-2595E-mail to: MagnesiumSulfateRecall@amneal.com.