Recall
FDAHealthMarch 18, 2026

Amneal Pharmaceuticals, LLC — 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

⚠️ 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.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
March 18, 2026

U.S.A. Nationwide

What's affected?

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.
Lot code
AH250162

Additional details

Lot: AH250162, Exp 8/31/2027

What should I do?

Recommended action

Class I recall. Voluntary: Firm initiated Quantity affected: 784 (12x100mL) cartons.

View original FDA notice →

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