Kowa Pharmaceuticals America recalls Livalo 4mg tablets due to foreign tablets/capsules in some bottles. Affected units: 90-count bottles with NDC 66869-404-90, manufactured by Patheon in Cincinnati, OH. No remedy specified in recall notice.
Presence of foreign tablets/capsules
Kowa Pharmaceuticals America is recalling Livalo 4mg tablets because some bottles contain foreign tablets or capsules. This could lead to incorrect medication intake if the foreign tablets are taken instead of the intended medication.
The recall is for foreign tablets or capsules inside the Livalo bottles. If these foreign tablets are taken instead of the intended medication, it could lead to incorrect dosing or medication interactions.
People who have a prescription for Livalo 4mg tablets with NDC 66869-404-90, manufactured by Patheon in Cincinnati, OH, are affected. Those who have the 90-count bottles with the specific lot number and expiration date are most at risk.
Check for Livalo 4mg tablets in 90-count bottles with NDC 66869-404-90, manufactured by Patheon in Cincinnati, OH, and lot number 3231300, expiring 8/2027.
Look for the NDC code 66869-404-90 on the bottle label to confirm if it's affected.
The recall is due to the presence of foreign tablets or capsules in some Livalo 4mg bottles, which could lead to incorrect medication intake.
Check for the NDC code 66869-404-90 on the bottle label, manufactured by Patheon in Cincinnati, OH, with lot number 3231300 and expiration 8/2027.
The recall notice does not specify a remedy, so contact Kowa Pharmaceuticals America for further instructions.
We’ve drafted a message you can send Kowa to request your refund or repair — edit it as you like.
Subject: Recall D-0258-2025 — Kowa Kowa Hello, I own a Kowa that is covered by recall D-0258-2025 from Kowa. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
