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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96379

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 24, 2025
Product types
Drug
Classifications
Class III
Statuses
Completed
Recalling firm wording
Kowa Pharmaceuticals America

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

1 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 1

Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by Kowa Company, Ltd, Nagoya, 462-0024 Japan, Marketed by Kowa Pharmaceuticals: Kowa Pharmaceuticals America Inc., Montgomery, AL 36117 USA NDC 66869-404-90 HDPE Bottle, congregated into a shrink wrapped 6-pack further congregated into 24 6-packs in a cardboard case

D-0258-2025
Recall number
D-0258-2025
Initiated
February 24, 2025
Classification
Class III
Status
Completed
Quantity
5,328 Bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign tablets

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of foreign tablets/capsules

Code information

Lot#: 3231300, Exp 8/2027

Distribution pattern

PA, OH, and TX