FDA recall D-0210-2025

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

Status

Ongoing

Initiation date

2024-12-23

Report date

2025-02-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northbrook, IL, United States

Primary source

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