AvKARE recalls 2 mg Pitavastatin tablets due to failed impurity specifications. This may pose a risk of harmful impurities in the medication. Affected lots expire 10/31/2025 and 05/31/2026.
Failed Impurity/Degradation Specifications
AvKARE is recalling 2 mg Pitavastatin tablets that may contain harmful impurities. This recall affects patients taking this medication as it could lead to health risks from the impurities.
The tablets failed impurity and degradation specifications, meaning they may contain harmful substances. This could lead to health risks for patients taking the medication as the impurities might cause adverse effects.
Patients prescribed Pitavastatin tablets by a doctor are affected. Those using the recalled lots (expiring 10/31/2025 or 05/31/2026) are most at risk.
Check for the brand AvKARE, product name Pitavastatin Tablets, 2 mg, 90 tablets per bottle. The recall includes specific lots: Lot 46211 (expires 10/31/2025), Lot 47683 (expires 05/31/2026), and Lot 46944 (expires 01/31/2026).
Look for the lot numbers and expiration dates listed in the recall: Lot 46211 (expires 10/31/2025), Lot 47683 (expires 05/31/2026), or Lot 46944 (expires 01/31/2026).
The tablets failed impurity and degradation specifications, which may mean they contain harmful substances that could cause health risks.
The recall record does not specify a remedy, so contact your doctor or pharmacist for guidance.
Lots 46211 (expires 10/31/2025), 47683 (expires 05/31/2026), and 46944 (expires 01/31/2026).
We’ve drafted a message you can send AvKARE to request your refund or repair — edit it as you like.
Subject: Recall D-0529-2025 — AvKARE AvKARE Hello, I own a AvKARE that is covered by recall D-0529-2025 from AvKARE. 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.