Agency: Food and Drug Administration (FDA) | Date: 20260408 | Units: 784 (12x100mL) cartons
This alert was compiled from official government recall data published by the FDA using automated analysis. All facts are sourced directly from official records. Last verified April 19, 2026.
Stock photo for illustration — not the actual recalled product. Photo by Camila Mofsovich on Unsplash
A Serious Medication Mix-Up: Amneal Pharmaceuticals Recall
Most product safety concerns are minor. This one is not. Amneal Pharmaceuticals LLC has initiated a nationwide product recall in the United States due to a potentially dangerous mix-up involving an injectable medication.
Background on Amneal Pharmaceuticals
Amneal Pharmaceuticals is a major player in the generic drug market. They manufacture and distribute a wide range of medications. This recall highlights the critical importance of accuracy and quality control in pharmaceutical production. While Amneal hasn't had widespread recalls, any error in injectable medications can have severe consequences.
The Hazard: Tranexamic Acid Found in Magnesium Sulfate Packaging
The heart of this product recall in the United States is a worrisome medication mix-up. Specifically, an IV bag labeled as Magnesium Sulfate in Water for Injection, 4 g/100 mL, actually contained Tranexamic Acid. The agency confirmed that this error could cause serious health problems for patients.
- Magnesium Sulfate is used for various conditions, including pre-eclampsia and seizures.
- Tranexamic Acid is used to control bleeding.
Using the wrong medication could lead to adverse reactions or inadequate treatment. American shoppers need to be aware of this risk.
Affected Products: Identifying the Recalled Medication
This product recall affects a specific lot of medication. The affected product is 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. in India, and distributed by Amneal Pharmaceuticals LLC in Bridgewater, NJ. Look for these details on your medication packaging.
- Product: Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag
- NDC: 70121-1720-3
- Lot Number: AH250162
- Expiration Date: 08/31/2027
- Units Affected: 784 (12x100mL) cartons
The product was distributed nationwide across the U.S. If you or a loved one received this medication, double-check the lot number.
What You Should Do Right Now
If you have this medication, it's important to take immediate action. Nobody wants to find out they have the wrong injectable drug. Here's a step-by-step guide for U.S. consumers:
- Immediately stop using Magnesium Sulfate in Water for Injection with lot number AH250162 and check if it matches the recalled product.
- Contact your healthcare provider right away if you received this medication, even if you haven't experienced any adverse effects, to discuss potential risks and next steps.
- Inform your pharmacy or the medical facility where you received the medication about this product recall, providing them with the lot number and other identifying information.
- Segregate the recalled product from other medications to prevent accidental use and await further instructions from Amneal Pharmaceuticals or your healthcare provider regarding its proper disposal or return.
- Monitor yourself for any unusual symptoms or changes in your health, and report them to your doctor promptly, especially if you received this medication recently.
Amneal Pharmaceuticals' Remedy
Amneal Pharmaceuticals is taking steps to address this product recall in the United States. Their focus is on preventing further mix-ups and ensuring patient safety. Their remedy involves stopping the use of the affected lot.
- Amneal is likely contacting healthcare providers and facilities directly.
- They will provide instructions on returning the recalled product.
Stay informed about the recall process. American shoppers can contact Amneal Pharmaceuticals LLC for more information.
This recall was announced by the U.S. Food and Drug Administration (FDA). For the official notice and complete details, visit www.fda.gov.Frequently Asked Questions
Q: What exactly is being recalled?
Amneal Pharmaceuticals is recalling a specific lot of Magnesium Sulfate in Water for Injection, 4g/100 mL IV bags, because some bags may contain Tranexamic Acid instead.
Q: How do I know if my medication is part of the recall?
Check the packaging for the following: Product name Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, NDC 70121-1720-3, Lot number AH250162, and Expiration Date 08/31/2027.
Q: What are the symptoms of receiving the wrong medication?
The symptoms can vary depending on the individual and the condition being treated, but possible symptoms of receiving Tranexamic Acid instead of Magnesium Sulfate might include blood clots, nausea, vomiting, or changes in blood pressure.
Q: Where was this medication sold?
The recalled Magnesium Sulfate was distributed throughout the U.S.A. nationwide, so it could have been administered in hospitals or clinics in any state.
Q: What should I tell my doctor about this recall?
Inform your doctor that you may have received a recalled lot of Magnesium Sulfate, providing the lot number (AH250162), and discuss any potential risks or side effects you might be experiencing based on your specific health condition.
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Stop using it right away and follow the steps above. You may be entitled to a full refund, free repair, or replacement at no cost.