FDA-Drug2026-04-08Class IPACKAGING DEFECT
Amneal Magnesium Sulfate IV bags recalled due to wrong medication inside packaging
LABEL MIX UPNationwide distribution
Stop using Amneal Magnesium Sulfate IV bags
Some cartons of Amneal Magnesium Sulfate IV bags were mislabeled and contained Tranexamic Acid (a different medication) instead. This mix-up affects lot AH250162 with an expiration date of 8/31/2027. The error was discovered before the product reached patients.
- Do not use IV bags from lot AH250162 (exp. 8/31/2027).
- Verify the medication inside matches the label before administering.
- Contact your pharmacy or hospital if you have this lot in stock.
- Report any use of the wrong medication to FDA MedWatch immediately.
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.
Sold states
U.S.A. Nationwide
Affected count
784 (12x100mL) cartons
Manufactured in
400 Crossing Blvd Fl 3, Bridgewater, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0478-2026More Amneal Pharmaceuticals, LLC recalls
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