# FDA recall D-0629-2024

> **Amneal Pharmaceuticals, LLC** · Class III · drug recall initiated 2024-08-01.

## Product

Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1

## Reason for recall

Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0629-2024
- **Recalling firm:** Amneal Pharmaceuticals, LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2024-08-01
- **Report date:** 2024-08-14

- **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-0629-2024

## Citation

> AI Analytics. FDA recall D-0629-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0629-2024. Source: US FDA. Licensed CC0.

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