Amneal Magnesium Sulfate IV Bag Recall 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, Manufactu
Updated March 18, 2026
Amneal Pharmaceuticals is recalling specific lots of Magnesium Sulfate IV bags because some pouches labeled as Magnesium Sulfate actually contain Tranexamic Acid, a completely different drug. Receiving the wrong IV medication can cause serious or life-threatening harm.
Is the Amneal Pharmaceuticals, LLC recalled? Yes. This product was recalled by FDA on March 18, 2026. Details below.
What is recalled
Magnesium Sulfate in Water for Injection, 4 g/100 mL (40 mg/mL) IV bags, packaged in cartons of 12 × 100 mL IV bags. Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad, India. Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 70121-1720-3.
Am I affected
You (or your facility) are affected if you have cartons or individual IV bags with NDC 70121-1720-3, labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL (40 mg/mL)," distributed by Amneal Pharmaceuticals LLC. Check the foil pouch label and the carton NDC number against these identifiers.
What to do right now
Stop using this product immediately. Quarantine and do not administer any IV bags matching NDC 70121-1720-3, the pouch may actually contain Tranexamic Acid instead of Magnesium Sulfate. Contact Amneal Pharmaceuticals LLC in Bridgewater, NJ, or visit the FDA recall page at https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts for return and replacement instructions.
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.
Brands affected
- Source
- FDA
- Category
- Drugs & Medications
- Recall ID
- fda-D-0478-2026
- Classification
- Class I
- Recalled
- March 18, 2026
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