FDA Recall D-0478-2026

Amneal Pharmaceuticals, LLC · Bridgewater, NJ

Class I — life-threatening Ongoing 57 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

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: Lot: AH250162, Exp 8/31/2027

Quantity: 784 (12x100mL) cartons

Reason for recall

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.

Recall record

Recall number: D-0478-2026
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: U.S.A. Nationwide
Recall initiated: 2026-03-18
Classified by FDA Center: 2026-04-13
FDA published: 2026-04-08
Recalling firm: Amneal Pharmaceuticals, LLC
Firm location: Bridgewater, NJ

Drug identification

Brand name(s): MAGNESIUM SULFATE
Generic name(s): MAGNESIUM SULFATE IN WATER FOR
Manufacturer(s): Amneal Pharmaceuticals LLC
NDC(s): 70121-1719, 70121-1720
Route(s): INTRAVENOUS

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All recalls