Magnesium sulfate pouch recalled as Class I for containing tranexamic acid
One lot of Magnesium Sulfate in Water for Injection is being recalled after a foil pouch labeled as magnesium sulfate was found to contain an IV bag of tranexamic acid.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The rubric states an FDA Class I recall is never scored below 4, and this record carries a Class I classification with no reported deaths in the source.
Plain-English summary
Magnesium Sulfate in Water for Injection is being recalled. About 784 cartons of 12 x 100 mL were distributed nationwide in the United States.
The recall was initiated for a product mix up: a foil pouch labelled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of tranexamic acid instead. The FDA has classified this recall as Class I, its most serious category.
Affected product is lot AH250162 with an expiry date of 8/31/2027.
Clinicians and pharmacies can identify affected product by the lot number and expiry date above, and may contact the recalling firm for further information.
The recalled product
- Product
- MAGNESIUM SULFATE (MAGNESIUM SULFATE IN WATER FOR)
- Brand
- MAGNESIUM SULFATE
- Manufacturer
- Amneal Pharmaceuticals, LLC
- Category
- Drug — Injectable
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: AH250162
- Exp 8/31/2027
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Amneal Pharmaceuticals, LLC
See all →- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- ModeratePrimidone tablets recalled over potential acemetacin cross-contamination at API manufacturer
FDA (Drugs) · 2026-06-17
- HighAmneal tramadol tablets failed nitrosamine impurity specification at stability
FDA (Drugs) · 2026-04-08
- ModerateChlorpromazine 25 mg tablets recalled after micro-organism found on packaging coil
FDA (Drugs) · 2025-09-10
- ModerateChlorpromazine 100 mg tablets recalled over micro-organism on packaging coil
FDA (Drugs) · 2025-09-10
Same hazard · product mixup
See all →- HighMonoject tuberculin syringe packages actually contain U-100 insulin syringes
FDA (Devices) · 2026-04-08
- ModeratePitavastatin 2 mg bottle found to contain a 1 mg tablet
FDA (Drugs) · 2026-03-25
- ModerateMedartis APTUS TriLock screw lots mixed 2.5 mm and 2.8 mm
FDA (Devices) · 2026-03-18
- ModerateMedartis APTUS 2.5 TriLock screw lots mixed with 2.8 mm
FDA (Devices) · 2026-03-18
- ModerateBD syringe batch may contain Luer Slip instead of Luer Lok
FDA (Devices) · 2026-03-18
Similar recalls
- LowHospira Recalls Magnesium Sulfate Injection Due to High Potency
FDA (Drugs) · 2012-06-27
- SevereMagnesium Sulfate Injection Recalled Due to Mispackaged Heparin Unit
FDA (Drugs) · 2018-10-17
- SevereSCA Pharmaceuticals Recalls Leaking Magnesium Sulfate Injectable Bags
FDA (Drugs) · 2017-06-07
- SevereMagnesium Sulfate Injectable Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- CriticalHospira Recalls Magnesium Sulfate Injection Bags Due to Incorrect Barcode Labeling
FDA (Drugs) · 2016-02-24
- SevereMagnesium Sulfate Injection Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2014-01-22