Endo Everolimus Tablets 10mg Recall: Impurity Risk

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Contact the company & request your remedy

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 10mg Everolimus tablets that failed impurity testing. This could pose a risk to patients taking the medication as it may contain harmful substances.

Why it’s dangerous

The tablets failed impurity testing for a specific chemical (IP-C). This could mean the medication contains harmful substances that might affect patient safety when taken as prescribed.

Who’s affected

Prescription patients using the specific lots of Everolimus tablets manufactured by Par Pharmaceutical in Chestnut Ridge, NY. Those with the listed lot numbers are most at risk.

How to tell if you have this one

Check your Everolimus tablets for the lot numbers 550162801 (expires Nov 2025) or 550169801 (expires Jan 2026). These were manufactured by Par Pharmaceutical in Chestnut Ridge, NY.

Brand
Endo
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Your Lot Number
Look for the lot numbers 550162801 or 550169801 on the packaging.

✎ GovInfoNow

Questions people ask

Why is this medication being recalled?

The tablets failed impurity testing for a specific chemical (IP-C), which could mean they contain harmful substances.

What should I do if I have these tablets?

The official recall notice does not specify a remedy for this product. Check your lot number and contact your doctor or pharmacist for guidance.

Are there any other products affected?

The recall only affects the specific lot numbers 550162801 and 550169801 of Everolimus tablets 10mg, 28 tablets.

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-0141-2026 — Endo Endo

Hello,

I own a Endo that is covered by recall D-0141-2026 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-0141-2026 (October 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0141-2026 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 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured

Recall notice