Astagraf XL (tacrolimus extended-release capsules) 0.5 mg recall
FDA recall D-0210-2025 · initiated Dec 23, 2024
Astellas Pharma US Inc. recalled Astagraf XL (tacrolimus extended-release capsules) 0.5 mg in Dec 2024 — an FDA Class I recall (D-0210-2025) because Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 3,500 30-count bottles
Details
- 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.
- Recalling company
- Astellas
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Dec 23, 2024
- FDA report date
- Feb 5, 2025
This recall is linked to a product we cover: Astagraf XL →
Frequently asked
- Was Astagraf XL (tacrolimus extended-release capsules) 0.5 mg recalled?
- Astellas Pharma US Inc. recalled Astagraf XL (tacrolimus extended-release capsules) 0.5 mg in Dec 2024 — an FDA Class I recall (D-0210-2025) because Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Astagraf XL (tacrolimus extended-release capsules) 0.5 mg recalled?
- Per the FDA enforcement record, the reason for recall D-0210-2025 was: Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
- Is a recalled Astagraf XL (tacrolimus extended-release capsules) 0.5 mg dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Astagraf XL (tacrolimus extended-release capsules) 0.5 mg are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot# 0R3092A, EXP 03/31/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0210-2025.