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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…

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.

Class I Medicine & devices FDA April 8, 2026 Reached Texas
Read the official FDA notice →

What to do

Stop using the product and check it against the description above. This recall is in the most serious category, meaning the agency believes it can cause serious injury or death — don't finish the package or use up what's left. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.

Details

Recalling company
Amneal Pharmaceuticals, LLC — Bridgewater, NJ
Severity
Class I — serious
Reported
April 8, 2026
Quantity
784 (12x100mL) cartons
Recall number
D-0478-2026
Status
Ongoing
Source
FDA

Where it went

U.S.A. Nationwide

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