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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96008

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 23, 2024
Product types
Drug
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Astellas Pharma US Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 2

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.

D-0210-2025
Recall number
D-0210-2025
Initiated
December 23, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Astellas Pharma US Inc.
Quantity
3,500 30-count bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules

Code information

Lot# 0R3092A, EXP 03/31/2026

Distribution pattern

Nationwide in the USA

drug · product 2 of 2

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.

D-0211-2025
Recall number
D-0211-2025
Initiated
December 23, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Astellas Pharma US Inc.
Quantity
14,340 100-count bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules

Code information

Lot# 0E3353D, Exp 03/31/2026

Distribution pattern

Nationwide in the USA