Amneal Pharmaceuticals, LLC recalls Magnesium Sulfate in Water for Injection
- Recalling company
- Amneal Pharmaceuticals, LLC
- 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, 382110, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1720-3.
- Reason
- 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.
- Classification
- Class I – a reasonable probability that use will cause serious adverse health consequences or death
- Recall date
- Mar 18, 2026
- Reported
- Apr 8, 2026
- Distribution
- U.S.A. Nationwide
- Status
- Ongoing
- Quantity
- 784 (12x100mL) cartons
- Lot / codes
- Lot: AH250162, Exp 8/31/2027
- Company location
- Bridgewater, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0478-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0478-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.