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Moderate recall: A hazard has been identified, with no injuries reported yet. Follow the steps below.

Kowa Pharmaceuticals America 2025-03-19 Health moderate FDA
Health · FDA · Recall #FDA-D-0258-2025

Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by:… Recall

Issued March 19, 2025 · Kowa Pharmaceuticals America

In March 2025, Kowa Pharmaceuticals America recalled the Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by:…, a moderate health recall reported by the FDA.

Compiled by Maya Ellison, RecallCheckr

What this means for you

Presence of foreign tablets/capsules

What you should do

  1. 1 Stop using Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by:… right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact Kowa Pharmaceuticals America to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
Kowa Pharmaceuticals America
Category
Health
Recall date
March 19, 2025
Units affected
Not reported
Sold at
PA, OH, and TX
Recall number
FDA-D-0258-2025
Made in
United States
Issuing agency
FDA

In context

  • Kowa Pharmaceuticals America has 1 recall in our database.
  • We're tracking 3,576 Health recalls in our database.
  • This is the 691st Health recall we've logged in 2025.
Read the official FDA notice

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