Home / Recalls / Amneal Pharmaceuticals, LLC / D-0478-2026

D-0478-2026 Class I Ongoing

Recalled by Amneal Pharmaceuticals, LLC — Bridgewater, NJ

Recall Details

Product Type
Drugs
Report Date
April 8, 2026
Initiation Date
March 18, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
784 (12x100mL) cartons

Product Description

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.

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.

Distribution Pattern

U.S.A. Nationwide

Code Information

Lot: AH250162, Exp 8/31/2027

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  • D-0613-2020 Class II — Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100- (November 22, 2019)