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Astellas Pharma Us Inc.

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Class I

  • The FDA’s most serious category — a reasonable probability of serious harm or death.
  • Refunds don't require a receipt, and you don't need proof of purchase.
  • FDA status: Ongoing.

What was recalled

Source: FDA · synced 29 Jul 2026 13:14
Check with your pharmacist Filed 2025-02-05

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

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.

Check these codes: Lot# 0R3092A, EXP 03/31/2026

3,500 30-count bottles · distributed nationwide in the usa Recall D-0210-2025 on FDA.gov ↗
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