Amneal Pharmaceuticals, LLC drug recall: Magnesium Sulfate in Water for Injection
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Drugs
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 98587
- Recall initiated
- Mar 18, 2026
- Classified by FDA
- Apr 13, 2026
- Posted in Enforcement Report
- Apr 8, 2026
- Recalling firm
- Amneal Pharmaceuticals, LLC
- Firm location
- Bridgewater, NJ, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
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.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Mar 18, 2026. FDA classified it 26 days later, on Apr 13, 2026. Distribution reported by FDA: U.S.A. Nationwide Amneal Pharmaceuticals, LLC has 16 recalls in our records.
Recalled products (1)
D-0478-2026 Class I Ongoing
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.
Codes / lots: Lot: AH250162, Exp 8/31/2027
Quantity: 784 (12x100mL) cartons
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA drug enforcement dataset
- Official notice
- FDA Enforcement Report, event 98587
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.