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COMPANY ANNOUNCEMENT

# Amneal Pharmaceuticals LLC Announces Voluntary Countrywide Recall of Magnesium Sulfate in Water for Injection, USP 4 g/100mL (NDC 70121-1720-3) Caused by a Product Mix-up with Tranexamic Acid in 0.7% Sodium Chloride Injection, 10 mg/mL

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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## 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.

Delay in magnesium therapy possesses reasonable probability of life-threatening morbidity. This affects pregnant individuals with preeclampsia. Seizures constitute the potential development. Delay signifies similar risk in eclampsia. Delay in magnesium therapy exhibits potential for long-term morbidity. This impacts pregnant individuals with preeclampsia. Seizures denote the cause. Delay originates comparable effects in eclampsia. Delay in magnesium therapy possesses potential for long-term morbidity. This affects preterm pregnant individuals. Long-term morbidity impacts the preterm neonate. Complications of prematurity comprise the reason. Amneal possesses no adverse event reports. These relate to this recall.

Magnesium sulfate signifies indication for seizure prevention. This comprises preeclampsia. It includes eclampsia. Control denotes the purpose.

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.

Mix-up possesses low likelihood of reaching patients. Hospital controls provide multiple safety checks. These precede administration. Amneal conducted thorough examination of 74% of remaining Magnesium Sulfate pouches. These pouches reside in Amneal's possession. Examination identified no product mix issue. Each Tranexamic Acid IV bag exhibits clear labeling. Labeling includes the product name. It comprises a readable bar code. Incorrect identification demonstrates ready detectability.

Amneal notifies distributors by UPS. Amneal requests distributors to notify hospital customers. Notification concerns the product recall. Hospitals possess Magnesium Sulfate in Water for Injection. This product undergoes recall. Hospitals should cease usage. Hospitals should return the product to Amneal. Product returns to Amneal Pharmaceuticals. Address denotes Magnesium Sulfate Recall Coordinator. Location comprises 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.

## Company Contact Information

Consumers:
  Amneal Pharmaceuticals
  833-582-0812
  MagnesiumSulfateRecall@amneal.com

## Product Photos

- ## Content current as of:

  03/24/2026

- ## Regulated Product(s)

  - Drugs

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## The Essentials

Lot and NDC info

### Key Facts

01 | Inspected 74% of remaining pouches.
02 | Magnesium dose: 4g/100mL.
03 | For preeclampsia/eclampsia seizure prevention.
04 | TXA for hemophilia hemorrhage reduction.
05 | Low likelihood of patient exposure.
06 | FDA MedWatch for reporting.

Summary FDA MedWatch available for reporting any related problems.

### Definitions

Wholesaler
  A distributor that supplies pharmaceuticals to hospitals, pharmacies, and other healthcare providers.
Preterm Neonate
  A newborn delivered before 37 weeks gestation, at risk for complications of prematurity.
Antifibrinolytic
  A drug that prevents fibrinolysis, the breakdown of blood clots, to reduce bleeding.
Sodium Chloride Injection
  A sterile solution of 0.7% or other concentrations used as a diluent or vehicle for IV medications.
Magnesium Sulfate
  A medication used intravenously to prevent and control seizures in pregnant individuals with preeclampsia or eclampsia.

### Quick Q&A

What is lot number of recall?

The specific lot recalled is AH250162, distributed between December 22, 2025, and February 27, 2026, to wholesalers and distributors nationwide.

Who should return the product?

Hospitals that received the recalled Magnesium Sulfate lot should stop using it and return it to Amneal Pharmaceuticals at 21 Colonial Drive, Piscataway, NJ 08854.

How to contact Amneal about recall?

Contact Amneal at 833-582-0812 (Mon-Fri 8am-5pm EST), fax 631-983-2595, or email MagnesiumSulfateRecall@amneal.com for questions.

What is preeclampsia?

Preeclampsia is a pregnancy complication characterized by high blood pressure and potential organ damage, where magnesium sulfate is used to prevent and control seizures.

What does eclampsia involve?

Eclampsia is a severe progression of preeclampsia involving seizures in pregnant individuals, treated preventively with magnesium sulfate to avoid life-threatening outcomes.