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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Magnesium Sulfate IV Bags Recalled for Product Mix-Up with Tranexamic Acid

Agency Publication Date: April 1, 2026
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Summary

Amneal Pharmaceuticals, LLC is recalling 784 cartons of Magnesium Sulfate in Water for Injection (4 g/100 mL) due to a product mix-up. Some foil pouches labeled as Magnesium Sulfate actually contain an IV bag of Tranexamic Acid instead. This recall affects one specific lot of IV bags distributed to hospitals and clinics nationwide.

Risk

Administering Tranexamic Acid instead of Magnesium Sulfate can lead to serious health complications, as the two drugs have entirely different medical purposes. No injuries have been reported to date, but the error could result in a patient receiving the wrong medication during critical hospital treatment.

What You Should Do

  1. Identify if you have the recalled product by checking for Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bags with NDC 70121-1720-3.
  2. Check the outer carton or foil pouch for lot number AH250162 and an expiration date of 8/31/2027.
  3. Stop using the recalled product immediately.
  4. Contact Amneal Pharmaceuticals, LLC or your distributor to arrange for the return of the affected IV bags.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

📋Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Magnesium Sulfate in Water for Injection (4g/100 mL)
Variants: 40mg/mL, IV bag, Carton of 12 x 100 mL IV bags, Rx only
Lot Numbers:
AH250162 (Exp 8/31/2027)
NDC:
70121-1720-3

Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad, India.

Product Images

Image of Magnesium Sulfate in Water for Injection, USP 4 g/100mL foil package

Image of Magnesium Sulfate in Water for Injection, USP 4 g/100mL foil package

Image of Tranexamic Acid in 0.7% Sodium Chloride Injection, 10 mg/mL IV bag

Image of Tranexamic Acid in 0.7% Sodium Chloride Injection, 10 mg/mL IV bag

Image of Magnesium Sulfate in Water for Injection, USP 4 g/100mL carton label

Image of Magnesium Sulfate in Water for Injection, USP 4 g/100mL carton label

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98587
Status: Active
Manufacturer: Amneal Pharmaceuticals, LLC
Sold By: Hospitals; Clinics
Manufactured In: India, United States
Units Affected: 784 (12x100mL) cartons
Distributed To: Nationwide
Agency Last Updated: April 13, 2026

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.