Medications & Supplements/Prescription Drugs

Livalo (pitavastatin) Tablets Recalled for Foreign Tablets or Capsules

Agency Publication Date: March 7, 2025

Summary

Kowa Pharmaceuticals America has recalled approximately 5,328 bottles of Livalo (pitavastatin) 4 mg tablets (90-count bottles) because the bottles may contain foreign tablets or capsules from other medications. This prescription drug is used to treat high cholesterol. The recall involves specific lot number 3231300 with an expiration date of August 2027.

Risk

Ingesting an unintended medication instead of your prescribed dose could lead to unexpected side effects, allergic reactions, or ineffective treatment of your condition.

What You Should Do

The recalled product is Livalo (pitavastatin) tablets, 4 mg, packaged in 90-count bottles (NDC 66869-404-90) with lot number 3231300 and an expiration date of August 2027 (8/2027).
If you have health concerns or believe you have consumed an incorrect medication, contact your healthcare provider or pharmacist immediately.
Return any unused product to the place of purchase for a refund, throw it away, or contact Kowa Pharmaceuticals America for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Livalo (pitavastatin) tablets (90-count)

Variants: 4 mg, 90-count bottles, Rx only

Lot Numbers:

3231300 (Exp 8/2027)

NDC:

66869-404-90

Manufactured by: Patheon, Inc. Cincinnati, OH or Kowa Company, Ltd, Nagoya, Japan. Packaging: HDPE Bottle in shrink-wrapped 6-pack.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96379

Status: Resolved

Manufacturer: Kowa Pharmaceuticals America

Manufactured In: United States, Japan

Units Affected: 5,328 Bottles

Distributed To: Pennsylvania, Ohio, Texas

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

The recalled product is Livalo (pitavastatin) tablets, 4 mg, packaged in 90-count bottles (NDC 66869-404-90) with lot number 3231300 and an expiration date of August 2027 (8/2027).

If you have health concerns or believe you have consumed an incorrect medication, contact your healthcare provider or pharmacist immediately.

Return any unused product to the place of purchase for a refund, throw it away, or contact Kowa Pharmaceuticals America for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.