Exact FDA event identifier

Event 98587

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: March 18, 2026
Product types: Drug
Classifications: Class I
Statuses: Ongoing
Recalling firm wording: Amneal Pharmaceuticals, LLC

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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.

D-0478-2026

Recall number: D-0478-2026
Initiated: March 18, 2026
Classification: Class I
Status: Ongoing
Recalling firm: Amneal Pharmaceuticals, LLC
Quantity: 784 (12x100mL) cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

Lot: AH250162, Exp 8/31/2027

Distribution pattern

U.S.A. Nationwide