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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot# 0E3353D, Exp 03/31/2026
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Astellas Pharma US Inc.
- Reason for Recall:
- Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full 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.
Product Codes/Lot Numbers:
Lot# 0E3353D, Exp 03/31/2026
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0211-2025
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