Recall of Magnesium Sulfate in Water for Injection by Amneal Pharmaceuticals
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Amneal Pharmaceuticals LLC is recalling 784 cartons of Magnesium Sulfate in Water for Injection due to a product mix-up with Tranexamic Acid, affecting IV bags distributed nationwide in the U.S.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 14, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
Amneal Pharmaceuticals LLC is recalling Magnesium Sulfate in Water for Injection due to a product mix-up, where an IV bag inside a labeled foil pouch was identified as containing Tranexamic Acid instead.
Which Products Are Affected
The affected product is Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags. The product is manufactured by Amneal Pharmaceuticals Pvt. Ltd. and distributed by Amneal Pharmaceuticals LLC. It has NDC codes 70121-1720-3, and the affected lot is AH250162 with an expiration date of August 31, 2027. A total of 784 cartons are involved, distributed nationwide in the U.S.A.
What You Should Do
Consumers should follow the initial firm notification, which was issued via letter, and contact Amneal Pharmaceuticals LLC at their address: 400 Crossing Blvd Fl 3, Bridgewater, NJ 08807-2863, for information on returns or refunds.
Why This Matters
This recall is significant because a product mix-up in prescription drugs could lead to incorrect administration and potential health risks for patients.
Source
Attribution: FDA. For more information, refer to the FDA's recall database using the event ID 98587.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,228 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to April 14, 2026.
Frequently Asked Questions
Common questions about this FDA recall.