# FDA recall D-0478-2026

> **Amneal Pharmaceuticals, LLC** · Class I · drug recall initiated 2026-03-18.

## 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.

## Distribution

U.S.A. Nationwide

## Key facts

- **Recall number:** D-0478-2026
- **Recalling firm:** Amneal Pharmaceuticals, LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-03-18
- **Report date:** 2026-04-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bridgewater, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0478-2026

## Citation

> AI Analytics. FDA recall D-0478-2026. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0478-2026. Source: US FDA. Licensed CC0.

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