Drug recall D-0478-2026
Product
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.
Reason for recall
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.
Lots and codes
Lot: AH250162, Exp 8/31/2027
Recall details
- Recalling firm
- Amneal Pharmaceuticals, LLC, Bridgewater, NJ
- Quantity
- 784 (12x100mL) cartons
- Distribution
- U.S.A. Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 18, 2026
Related products
- Magnesium Sulfate – drug information
- NDC 70121-1720 Magnesium Sulfate · Magnesium Sulfate Heptahydrate 40 mg/mL · Amneal Pharmaceuticals LLC
- NDC 70121-1719 Magnesium Sulfate · Magnesium Sulfate Heptahydrate 40 mg/mL · Amneal Pharmaceuticals LLC