Endo Everolimus Tablets 2.5mg Recall: Impurity Risk in Rx Only Medication

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Recalling firmEndo USA, Inc.9 Great Valley Pkwy, N/A · Malvern, PA 19355-1304

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Endo is recalling 2.5mg Everolimus tablets that failed impurity testing. This could mean the medication is unsafe for patients using it as prescribed.

Why it’s dangerous

The tablets contain an impurity (IP-C) that failed quality testing. This impurity could potentially cause harm if the medication is taken as directed.

Who’s affected

Patients prescribed Everolimus tablets by a doctor are affected. Those using the medication without a prescription are not impacted.

How to tell if you have this one

Check your carton for the lot numbers 550172201, 550184801, or 550204001 and expiration dates of January 2026, March 2026, or July 2026.

Brand
Endo
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Carton Details
Look for lot numbers 550172201, 550184801, or 550204001 and expiration dates of January 2026, March 2026, or July 2026.

✎ GovInfoNow

Questions people ask

Is this medication safe to take?

The official recall notice states the tablets failed impurity testing, but does not specify if they are safe to take.

What should I do if I have these tablets?

The recall record does not provide a remedy or action steps for affected patients.

How can I check if my tablets are recalled?

Check your carton for lot numbers 550172201, 550184801, or 550204001 and expiration dates of January 2026, March 2026, or July 2026.

Take action

Contact Endo

We’ve drafted a message you can send Endo to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall D-0142-2026 — Endo Endo

Hello,

I own a Endo that is covered by recall D-0142-2026 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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Where this comes from

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.

Official source: FDA Recall #D-0142-2026 (October 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0142-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Endo USA, Inc. recalls Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only,

Recall notice