February 2025 FDA Recall Livalo by Kowa Pharmaceuticals America
D-0258-2025 - Presence of foreign tablets/capsules
This Class III drug recall was voluntarily initiated by Kowa Pharmaceuticals America on February 24, 2025 for the product Livalo. The FDA reported the reason for recall as presence of foreign tablets/capsules. The product was distributed in PA, OH, and TX and the recall is currently completed.
Recall Number: D-0258-2025
Presence of foreign tablets/capsules
02-24-2025
03-19-2025
5,328 Bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Kowa Pharmaceuticals America
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
PA, OH, and TX
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
