# FDA recall D-0210-2025

> **Astellas Pharma US Inc.** · Class I · drug recall initiated 2024-12-23.

## Product

Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by: Astellas Pharma US Inc., Northbrook, IL 60062, NDC 0469-0647-73.

## Reason for recall

Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0210-2025
- **Recalling firm:** Astellas Pharma US Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-12-23
- **Report date:** 2025-02-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northbrook, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0210-2025

## Citation

> AI Analytics. FDA recall D-0210-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/D-0210-2025. Source: US FDA. Licensed CC0.

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