FDA Drugs recall ·
Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0478-2026
- Date
- (initiated March 18, 2026)
- Company / brand
- Amneal Pharmaceuticals, LLC
400 Crossing Blvd Fl 3, Bridgewater, NJ, United States - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 784 (12x100mL) cartons
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: AH250162, Exp 8/31/2027
Distribution
U.S.A. Nationwide
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0478-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.