Class I · High risk
Prograf (tacrolimus)
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Astagraf XL (Tacrolimus Extended-Release Capsules)
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
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.
Affected NDC
0469-0647-73
Compare with the code on your package — it is the most precise check available.
Drug: Tacrolimus
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Astagraf Xl tacrolimus extended-release capsules NDC 00469-0647 |
TACROLIMUS .5 mg/1 | Capsule, Coated, Extended Release Oral |
Astellas Pharma US, Inc. | Rx |
- Recalling firm
- Astellas Pharma US Inc.
- NDC code
- 0469-0647-73
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0210-2025 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
Other Tacrolimus recalls
See all
Class II · Moderate risk
Tacrolimus Capsules
Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.
Class II · Moderate risk
Tacrolimus Capsules
Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.
Class II · Moderate risk
Tacrolimus 0.03% Oph Solution Tacrolimus 0.1%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class III · Low risk
Tacrolimus Ointment
Defective Container: Tube split from side seam
Other recalls by Astellas Pharma US Inc.
All 2024 recalls
Class I · High risk
Prograf (tacrolimus)
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Class II · Moderate risk
Mycamine (micafungin)
Labeling: Label Error on Declared Strength
Class II · Moderate risk
Tarceva (erlotinib)
Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine stability testing.
Class II · Moderate risk
AmBisome (amphotericin B)
Lack of Assurance of Sterility; Astellas Pharma US, Inc. is performing a voluntary recall on certain lots of AmBisome because the manufacturer has notified Astellas that during a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in the media fills.
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