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Amneal Pharmaceuticals, LLC recalls Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags

Recalled April 8, 2026 · FDA recall D-0478-2026 · Amneal Pharmaceuticals

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. · FDA Class I
Units
784 (12x100mL) cartons
Sold at
U.S.A. Nationwide

Description

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.

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.
Manufacturer(s)
Amneal Pharmaceuticals, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Amneal Pharmaceuticals, LLC recalls Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags | RecallWatchUSA