Drug FDA Class I Ongoing Mislabeling
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.
Amneal Pharmaceuticals, LLC Published Apr 8, 2026
Risk level
Class IDangerous or defective — could cause serious health problems or death.
Severity score 85/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact Amneal Pharmaceuticals, LLC or your place of purchase with questions, and see the source record below for full details.
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 products (1)
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.
MAGNESIUM SULFATE · 784 (12x100mL) cartons
NDC: 70121-1719, 70121-1720, 70121-1719-9, 70121-1719-2, 70121-1720-9, 70121-1720-3
Lot codes: AH250162
Code info: Lot: AH250162, Exp 8/31/2027
Affected areas
Nationwide
Timeline
- InitiatedMar 18, 2026
- PublishedApr 8, 2026
- Recall number
- D-0478-2026
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.