Endo Everolimus Tablets 5mg Recall: Impurity Risk in Rx Only Medication

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Contact the company & request your remedy

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

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Endo is recalling 5mg Everolimus tablets that failed impurity testing. This could lead to unsafe drug levels in patients taking these medications. Patients should not use the recalled tablets and contact their pharmacy for alternatives.

Why it’s dangerous

The tablets failed impurity testing for IP-C, which could mean unsafe drug levels. This might cause adverse effects in patients taking the medication. The exact health risks are not specified in the recall notice.

Who’s affected

Patients prescribed Everolimus tablets 5mg by a doctor are affected. Those using the recalled lot numbers and expiration dates are at risk.

How to tell if you have this one

Check the product label for the lot numbers: 550184901, 550185001 (expiring March 2026), 550189901, 550190001 (expiring April 2026), or 550203901, 550205601 (expiring July 2026). The medication is prescription-only and sold in cartons with 28 tablets.

Brand
Endo
Category
Drug

Based on the official FDA remedy

What to do — step by step

Stop Using Tablets
Discard the recalled Everolimus tablets immediately if you have them.

✎ GovInfoNow

Questions people ask

Are these tablets safe to take?

The recall states the tablets failed impurity testing, so they are not safe to take. Contact your pharmacy for alternatives.

What lot numbers are recalled?

The recalled lot numbers are 550184901, 550185001 (expiring March 2026), 550189901, 550190001 (expiring April 2026), and 550203901, 550205601 (expiring July 2026).

How do I know if I have the recalled product?

Check the product label for the specific lot numbers listed in the recall notice.

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-0139-2026 — Endo Endo

Hello,

I own a Endo that is covered by recall D-0139-2026 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-0139-2026 (October 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0139-2026 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 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured

Recall notice