CLASS I ONGOING Drug recall · Reported 8 Apr 2026 · FDA Enforcement Report
Magnesium Sulfate in Water for Injection (40mg/mL) IV recalled
Amneal Pharmaceuticals is recalling Magnesium Sulfate in Water for Injection (40mg/mL) IV, distributed nationwide in the US. The recall was initiated on 18 Mar 2026 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0478-2026
- FDA event ID
- 98587
- Recalling firm
- Amneal Pharmaceuticals, Bridgewater, NJ
- Brand
- Magnesium Sulfate
- Manufacturer
- Amneal Pharmaceuticals LLC
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 18 Mar 2026
- FDA classified
- 13 Apr 2026
- Reported
- 8 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 18 Mar 2026 | Recall initiated by company | |
| 8 Apr 2026 | Published in enforcement report | +21 days |
| 13 Apr 2026 | Classified by FDA | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
U.S.A. Nationwide
Questions about this recall
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.
Which lots are affected?
Lot: AH250162, Exp 8/31/2027
Where was it sold?
U.S.A. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Magnesium recalls
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Meijer Magnesium Citrate Saline Laxative Oral Solution Dye recalledMagnesium Citrate | Pharma Nobis | Sterility | Nationwide |
| Drug | CLASS II | Walgreens Dye-Free Magnesium Citrate Saline Laxative/Oral recalledMagnesium Citrate | Pharma Nobis | Sterility | Nationwide |
| Drug | CLASS II | Good Neighbor Pharmacy, Dye Free recalled by Pharma NobisMagnesium Citrate | Pharma Nobis | Sterility | Nationwide |
| Drug | CLASS I | Equaline magnesium citrate saline laxative recalled by Vi-JonCitroma | Vi-Jon | Sterility | Nationwide |
| Drug | CLASS II | Magnesium Citrate Saline Laxative, Oral Solution recalled by Vi-JonCitroma | Vi-Jon | Manufacturing (CGMP) Deviations | Nationwide |