Magnesium Sulfate in Water for Injection recall
FDA recall D-0478-2026 · initiated Mar 18, 2026
Amneal Pharmaceuticals, LLC recalled Magnesium Sulfate in Water for Injection in Mar 2026 — an FDA Class I recall (D-0478-2026) because 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.
Most serious — a reasonable probability that use will cause serious harm or death.
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.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 784 (12x100mL) cartons
Details
- 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.
- Recalling company
- Amneal
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S.A. Nationwide
- Initiated
- Mar 18, 2026
- FDA report date
- Apr 8, 2026
Frequently asked
- Was Magnesium Sulfate in Water for Injection recalled?
- Amneal Pharmaceuticals, LLC recalled Magnesium Sulfate in Water for Injection in Mar 2026 — an FDA Class I recall (D-0478-2026) because 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. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Magnesium Sulfate in Water for Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0478-2026 was: 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.
- Is a recalled Magnesium Sulfate in Water for Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Magnesium Sulfate in Water for Injection are affected?
- Distributed: U.S.A. Nationwide. The recall covers these lots — Lot: AH250162, Exp 8/31/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0478-2026.