Magnesium Sulfate in Water for Injection — Class I drug recall D-0478-2026
Ongoing recall by Amneal Pharmaceuticals, LLC, reported 2026-04-08, distributed nationwide. Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained
| Recall number | D-0478-2026 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amneal Pharmaceuticals, LLC, Bridgewater, NJ, United States |
| Recall initiated | 2026-03-18 |
| Classified | 2026-04-13 |
| Reported by FDA | 2026-04-08 |
| Distributed | Nationwide (US) |
| Quantity | 784 |
| Reason classes | labeling |
| NDC | 70121-1719, 70121-1719-02, 70121-1719-09, 70121-1720, 70121-1720-03, 70121-1720-09 |
| Lot numbers | AH250162 |
| Expiration dates | 2027-08-31 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0478-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.