Amneal Pharmaceuticals, LLC 2026-04-08 Health critical FDA
Health · FDA · Recall #FDA-D-0478-2026
Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in… Recall
Issued April 8, 2026 · Amneal Pharmaceuticals, LLC
In April 2026, Amneal Pharmaceuticals, LLC recalled the Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Amneal Pharmaceuticals, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Amneal Pharmaceuticals, LLC
- Category
- Health
- Recall date
- April 8, 2026
- Units affected
- Not reported
- Sold at
- U.S.A. Nationwide
- Recall number
- FDA-D-0478-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Amneal Pharmaceuticals, LLC has 6 recalls in our database, including 2 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 356th Health recall we've logged in 2026.