AvKARE recalls 1 mg Pitavastatin tablets (Rx only) due to failed impurity and degradation specifications. Affected lots expire 10/31/2025 and 09/30/2026. Consumers should contact for details.
Failed Impurity/Degradation Specifications
AvKARE is recalling 1 mg Pitavastatin tablets (90 tablets per bottle) that may have failed impurity or degradation specifications. This could pose a risk to users taking the medication as prescribed.
The tablets may have failed impurity or degradation specifications, which could affect the medication's safety and effectiveness. This means the tablets might not work as intended or could cause harm to users.
People with a prescription for AvKARE Pitavastatin tablets (1 mg, 90 tablets per bottle) manufactured in Pulaski, TN. Those who have the specific lots listed in the recall are most at risk.
Check your bottle for the brand 'AvKARE', product name 'Pitavastatin Tablets', 1 mg strength, 90 tablets per bottle, and prescription label. The specific lots are 46208 (expires 10/31/2025), 47738 (expires 09/30/2026), or 46943 (expires 05/31/2026).
Verify the lot number and expiration date on your bottle to see if it matches the recalled lots: 46208 (exp 10/31/2025), 47738 (exp 09/30/2026), or 46943 (exp 05/31/2026).
The tablets may have failed impurity or degradation specifications, which could affect safety and effectiveness.
Check the lot number and expiration date on your bottle. Affected lots are 46208 (exp 10/31/2025), 47738 (exp 09/30/2026), or 46943 (exp 05/31/2026).
The recall record does not specify a remedy, so contact AvKARE directly for instructions.
We’ve drafted a message you can send AvKARE to request your refund or repair — edit it as you like.
Subject: Recall D-0528-2025 — AvKARE AvKARE Hello, I own a AvKARE that is covered by recall D-0528-2025 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.
