Amneal Magnesium Sulfate IV Bag Recall, Product Mix Up
Summary
FDA classified a Class I recall for Amneal Pharmaceuticals' Magnesium Sulfate in Water for Injection (4g/100mL IV bags) after a product mix-up was discovered. A foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" was found to actually contain an IV bag of Tranexamic Acid instead. The affected lot (AH250162, expiration 8/31/2027) comprises 784 cartons distributed nationwide. The recall was initiated by the firm on March 18, 2026, and FDA classified it as Class I on April 13, 2026.
“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.”
What changed
FDA classified a Class I recall for Amneal Pharmaceuticals' Magnesium Sulfate in Water for Injection after discovering a product mix-up: foil pouches labeled as Magnesium Sulfate (4g/100mL) were found to contain Tranexamic Acid IV bags instead. Affected lot AH250162 (784 cartons, expiration 8/31/2027) was distributed nationwide. Class I is the most serious FDA recall classification, indicating reasonable probability of serious adverse health consequences or death.
Healthcare providers and patients should immediately check inventory for Lot AH250162 of Magnesium Sulfate IV bags and return the product through the firm's notification letter process. Pharmacies, hospitals, and other healthcare facilities that received this lot should verify their stock and coordinate returns with Amneal Pharmaceuticals.
Archived snapshot
Apr 20, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Amneal Pharmaceuticals, LLC
Drug Recalls (Class I)
← All Drug Recalls (Class I) Class I D-0478-2026 · 20260408 · Ongoing · Voluntary: Firm initiated
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, 3821...
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.
Affected Lot Numbers / Codes
Lot: AH250162, Exp 8/31/2027
Quantity
784 (12x100mL) cartons
Firm Notification Method
Letter
Distribution
U.S.A. Nationwide
Initiated
20260318
FDA Classified
20260413
Product Registration
Brand: MAGNESIUM SULFATE
Generic: MAGNESIUM SULFATE IN WATER FOR
Manufacturer: Amneal Pharmaceuticals LLC
Application: ANDA216597
NDC: 70121-1719, 70121-1720
Drug Label Context (from openFDA)
The following is from the manufacturer's FDA-approved drug label, not recall-specific. Provided for context.
Indications & Usage
INDICATIONS AND USAGE Magnesium sulfate in water for injection is indicated for the prevention and control of seizures in preeclampsia and eclampsia, respectively. When used judiciously it effectively prevents and controls the convulsions of eclampsia without producing deleterious depression of the central nervous system of the mother or infant. However, other effective drugs are available for this purpose.
Dosage & Administration
DOSAGE AND ADMINISTRATION Magnesium sulfate in water for injection is intended for intravenous use only. For the management of pre-eclampsia or eclampsia, intravenous infusions of dilute solutions of magnesium (1% to 8%) are often given in combination with intramuscular injections of 50% Magnesium Sulfate Injection, USP. Therefore, in the clinical conditions cited below, both forms of therapy are noted, as appropriate. Continuous maternal administration of magnesium sulfate in pregnancy beyond 5 to 7 days can cause fetal abnormalities. In Eclampsia In severe pre-eclampsia or eclampsia, the ...
Contraindications
CONTRAINDICATIONS Intravenous magnesium should not be given to mothers with toxemia of pregnancy during the two hours preceding delivery.
Warnings
WARNINGS FETAL HARM: Continuous administration of magnesium sulfate beyond 5 to 7 days to pregnant women can lead to hypocalcemia and bone abnormalities in the developing fetus. These bone abnormalities include skeletal demineralization and osteopenia. In addition, cases of neonatal fracture have been reported. The shortest duration of treatment that can lead to fetal harm is not known. Magnesium sulfate should be used during pregnancy only if clearly needed. If magnesium sulfate is given for...
Adverse Reactions
ADVERSE REACTIONS The adverse effects of parenterally administered magnesium usually are the result of magnesium intoxication. These include flushing, sweating, hypotension, depressed reflexes, flaccid paralysis, hypothermia, circulatory collapse, cardiac and central nervous system depression proceeding to respiratory paralysis. Hypocalcemia with signs of tetany secondary to magnesium sulfate therapy for eclampsia has been reported.
How Supplied
HOW SUPPLIED Magnesium Sulfate in Water for Injection is clear and colorless solution filled in intravenous bag and are supplied as 2 g/50 mL (40 mg/mL) and 4 g/100 mL (40 mg/mL). Each 50 mL contains 2 g of magnesium sulfate heptahydrate, USP (equivalent to 16.25 mEq magnesium) in water for injection and each 100 mL contains 4 g of magnesium sulfate heptahydrate, USP (equivalent to 32.5 mEq mag...
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