Class IOngoing

Magnesium Sulfate in Water for Injection recall

FDA recall D-0478-2026 · initiated Mar 18, 2026

Most serious — a reasonable probability that use will cause serious harm or death.

Why it was recalled

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.

Details

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.
Recalling company: Amneal
Classification: Class I
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: U.S.A. Nationwide
Initiated: Mar 18, 2026
FDA report date: Apr 8, 2026

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0478-2026 ↗

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