Why it was recalled
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.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot: AH250162, Exp 8/31/2027
Where it was sold
U.S.A. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0478-2026
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Mar 18, 2026
- FDA report date
- Apr 8, 2026
- Quantity
- 784 (12x100mL) cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amneal Pharmaceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-0478-2026, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 98587
- Address
- 400 Crossing Blvd Fl 3
- Code information
- Lot: AH250162, Exp 8/31/2027
- Postal code
- 08807-2863
- Report date
- Apr 8, 2026
- Product type
- Drugs
- Recall number
- D-0478-2026
- Classification
- Class I
- Recalling firm
- Amneal Pharmaceuticals, LLC
- Product quantity
- 784 (12x100mL) cartons
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Mar 18, 2026
- Initial firm notification
- Letter
- Center classification date
- Apr 13, 2026