Urgent site urgencyFDA Class I

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

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.

Agency
FDA Drug
Recall date
Mar 18, 2026
Status
Ongoing
Company
Amneal Pharmaceuticals, LLC
Image of Magnesium Sulfate in Water for Injection, USP 4 g/100mL foil package
Image supplied with the official CPSC notice.

1. What product was recalled?

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

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.

Quantity: 784 (12x100mL) cartons

Code or lot text: Lot: AH250162, Exp 8/31/2027

LOT
Exp 8/31/2027
LOT
Lot: AH250162
NDC
70121-1719
NDC
70121-1719-2
NDC
70121-1719-9
NDC
70121-1720
NDC
70121-1720-3
NDC
70121-1720-9
RECALL-NUMBER
D-0478-2026

2. Is my exact product affected?

Compare every printed identifier. A matching value can indicate that your product is included.

3. What is the hazard?

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.

4. What should I do now?

Follow the FDA recall notice and contact the recalling company for current instructions.

5. Where was it sold or distributed?

Nationwide

6. Were injuries or illnesses reported?

No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.

7. What remedy is available?

Follow the FDA recall notice and contact the recalling company for current instructions.

8. Is the recall active or closed?

The source status is Ongoing. The Recall Guy's urgency label is urgent, which is a separate deterministic site label.

9. When was the information checked?

Last checked .

  1. created

10. Where is the official source?

Open the official FDA Drug source

The Recall Guy normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.