Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag
Recalled by Amneal Pharmaceuticals, LLC
Class I — most serious
There is a reasonable chance that using this product could cause serious health problems or death.
Amneal Pharmaceuticals, LLC has recalled Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on April 8, 2026 and was initiated on March 18, 2026. It is classified as a Class I recall, which means there is a reasonable chance that using this product could cause serious health problems or death.
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, with approximately 784 (12x100mL) cartons affected. The company behind the recall is Amneal Pharmaceuticals, LLC, based in Bridgewater, NJ. The FDA describes the product as: “Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad, 382110, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgew…”
Why was Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag recalled?
According to the FDA, the stated reason for the recall is: “Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.”
What should you do?
If you think you may have bought Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, compare it against the product description and identifying codes (Lot: AH250162, Exp 8/31/2027) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Amneal Pharmaceuticals, LLC or your local health authority.
About this recall
This recall was distributed in NJ. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Full recall details
- Status
- Ongoing
- Date reported
- April 8, 2026
- Recall started
- March 18, 2026
- Distributed in
- NJ
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag recalled?+
According to the FDA: Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actua…
How serious is this recall?+
Class I — most serious. There is a reasonable chance that using this product could cause serious health problems or death.
What should I do if I have Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0478-2026. Information last synced from the FDA on July 5, 2026.