Why it was recalled
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Product description
Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062, NDC 0469-0607-73.
Lot numbers, UPCs & expiration codes
Lot# 0E3353D, Exp 03/31/2026
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0211-2025
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Dec 23, 2024
- FDA report date
- Feb 5, 2025
- Quantity
- 14,340 100-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Astellas Pharma US Inc.
Original FDA data
Every field from FDA enforcement report D-0211-2025, exactly as published.
Show all FDA fields
- City
- Northbrook
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 96008
- Address
- 2375 Waterview Dr
- Code information
- Lot# 0E3353D, Exp 03/31/2026
- Postal code
- 60062-6145
- Report date
- Feb 5, 2025
- Product type
- Drugs
- Recall number
- D-0211-2025
- Classification
- Class I
- Recalling firm
- Astellas Pharma US Inc.
- Product quantity
- 14,340 100-count bottles
- Reason for recall
- Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062, NDC 0469-0607-73.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Dec 23, 2024
- Initial firm notification
- Press Release
- Center classification date
- Jan 29, 2025