Astellas Pharma US Inc. 2025-02-05 Health critical FDA
Health · FDA · Recall #FDA-D-0211-2025
Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan,… Recall
Issued February 5, 2025 · Astellas Pharma US Inc.
In February 2025, Astellas Pharma US Inc. recalled the Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan,…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
What you should do
- 1 Stop using Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Astellas Pharma US Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Astellas Pharma US Inc.
- Category
- Health
- Recall date
- February 5, 2025
- Units affected
- Not reported
- Sold at
- Nationwide in the USA
- Recall number
- FDA-D-0211-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Astellas Pharma US Inc. has 1 recall in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.