Astellas Pharma US Inc. recalls Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by:…
- Recall date
- December 23, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0210-2025
- FDA classification
- Class I
- Brand / firm
- Astellas Pharma US Inc.
- Sold / distributed
- Nationwide in the USA
Why it was recalled
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
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.
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