Recall archive / FDA company announcement
Astellas: Tacrolimus and Tacrolimus Extended-Release capsules — FDA announcement Dec 24, 2024
Published notice; closure not supplied
A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.
Source date Dec 24, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Tacrolimus and Tacrolimus Extended-Release capsules
- Reason
- Bottles may contain empty capsules.
- Classification
- Not supplied
- Recalling firm
- Astellas Pharma US, Inc.
- Quantity
- Not supplied
- Agency-reported status
- Company recall announcement
- Source record identifier
- 709bad7a0dc5c11d
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | FOR IMMEDIATE RELEASE – NORTHBROOK, IL, Dec. 23, 2024 – Astellas Pharma US, Inc. (Head of US Commercial: Michael Petroutsas, "Astellas") is voluntarily recalling one lot of PROGRAF® 0.5mg (tacrolimus) and one lot of ASTAGRAF XL® 0.5mg (tacrolimus extended-release) capsules to the consumer level. These products are being recalled because bottles may contain empty capsules.; The affected lot numbers and expiration dates are:; Patients that have an affected lot should contact their physician or healthcare provider. Patients and physicians with questions should contact Astellas Medical Information at 1-800-727-7003 During office hours from 9 am to 5:30 pm EST, Monday through Friday.; PRODUCT DESCRIPTION | NDC | LOT NO. | EXP. DATE; PROGRAF® (tacrolimus) 0.5 mg capsules 100 capsules per bottle | 0469-0607-73 | 0E3353D | 03/2026; ASTAGRAF XL® (tacrolimus extended- release capsules) 0.5 mg capsules 30 capsules per bottle | 0469-0647-73 | 0R3092A | 03/2026 |
Match all identifying details in the current notice. A brand name alone is not enough.
Product tables from the announcement
These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.
| PRODUCT DESCRIPTION | NDC | LOT NO. | EXP. DATE |
|---|---|---|---|
| PROGRAF® (tacrolimus) 0.5 mg capsules 100 capsules per bottle | 0469-0607-73 | 0E3353D | 03/2026 |
| ASTAGRAF XL® (tacrolimus extended- release capsules) 0.5 mg capsules 30 capsules per bottle | 0469-0647-73 | 0R3092A | 03/2026 |
Announcement retrieved Oct 1, 2026. Official announcement.
Distribution
No other formulations or doses of the product are impacted, and sufficient supply of unaffected stock is available to replace the recalled lots. Product was distributed nationwide to wholesale and retail outlets.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Fda listing date
- Dec 24, 2024
- Company announcement date
- Dec 23, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.