Livalo Tablet, Film Coated
FDA Recall NDC 66869-404
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Livalo (NDC 66869-404). A significant event, classified as Class III, was initiated on Feb 24, 2025 by Kowa Pharmaceuticals America, Inc.. The reported reason for this action was: "Presence of foreign tablets/capsules"
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Completed
Presence of foreign tablets/capsules
Feb 24, 2025
Mar 19, 2025
5,328 Bottles
Recall Profile & Regulatory Data
Event ID
96379
Classification
Class III
Enforcement Status
Completed
Recalling Firm
Kowa Pharmaceuticals America
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
PA, OH, and TX
Product Description
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
Batch or Lot Expiration Information
Lot# : 3231300, Exp 8/2027
Affected Packages Involved in this Recall
66869-104-90Product
66869-204-90Product
66869-204-07Product
66869-404-90Product
66869-404-07Product
Class II Terminated
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Mar 15, 2021
Jun 02, 2021
453 bottles
Recall Profile & Regulatory Data
Event ID
87512
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
FL, GA, SC
Termination Date
Jun 17, 2024
Product Description
Livalo (pitavastatin) tablets 2 mg* Rx Only NdC 66869-204-90 Manufactured under license from: Kowa Company, Limited Tokyo 103-8433 Japan Tablets Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by Kowa Company, Ltd Nagoya 462-0024 Japan
Batch or Lot Expiration Information
Lot# 3193479
Affected Packages Involved in this Recall
66869-104-90Product
66869-204-90Product
66869-204-07Product
66869-404-90Product
66869-404-07Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
