Endo recalls Everolimus 7.5mg tablets due to impurity IP-C failing specifications. Rx-only medication with specific lot numbers and expiration dates. Consumers should contact Endo for details.
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Endo is recalling Everolimus 7.5mg tablets because they contain an impurity that failed quality tests. This could pose a health risk to people taking the medication as prescribed.
The tablets contain an impurity (IP-C) that did not meet quality standards. This impurity could potentially cause health issues when taken as directed, though the exact risk level is not specified in the recall.
People prescribed Everolimus 7.5mg tablets by a doctor who received the recalled lots (550167301, 550167401, 550185101, 550205701) are affected. Those using the medication for conditions like renal cell carcinoma or certain tumors are most at risk.
Check if your Everolimus 7.5mg tablets come in a carton with 28 tablets (4 blister strips of 7 tablets each). Look for lot numbers 550167301, 550167401, 550185101, or 550205701 with expiration dates through November 2025, March 2026, or July 2026.
Verify your Everolimus tablets have the specific lot numbers and expiration dates listed in the recall notice.
The recall states the tablets failed impurity tests, but the exact health risk is not specified. Endo has not provided details on potential harm.
Check for lot numbers 550167301, 550167401, 550185101, or 550205701 with expiration dates through November 2025, March 2026, or July 2026.
The recall does not specify a remedy. Contact Endo directly for instructions on what to do next.
We’ve drafted a message you can send Endo to request your refund or repair — edit it as you like.
Subject: Recall D-0140-2026 — Endo Endo Hello, I own a Endo that is covered by recall D-0140-2026 from Endo. 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.
