FDAFDA · Food and drugs·Recall number D-0478-2026
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, Bridgewater, NJ 08807, NDC 70121-1720-3.
Published April 8, 2026 · Recall initiated: March 18, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- MAGNESIUM SULFATE
- Manufacturer
- Amneal Pharmaceuticals, LLC
- Distributor
- U.S.A. Nationwide
- Lot
- Lot: AH250162, Exp 8/31/2027
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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