Class III · Lower riskActive recall
Everolimus
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numberLot #: 550184901, 550185001, Exp. Date MAR-26; 550189901, 550190001, Exp. Date APR-26 550203901, 550205601, Exp. Date Jul-26
Where it was soldNationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byPar Pharmaceutical Chestnut Ridge, NY 10977
| Brand name | EVEROLIMUS |
| Generic name | EVEROLIMUS |
| Active ingredient(s) | EVEROLIMUS |
| Distributed by / for | Endo USA, Inc. |
| NDC | 49884-125-91 |
Show the full FDA record
| Full product label | Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-125-91 |
| Recalling firm | Endo USA, Inc. |
| Distribution | Nationwide within the United States |
| Quantity | 6,655 cartons |
| Recall initiated | 2025-10-10 |
| Report date | 2025-11-05 |
| Recall completed | — |
| Recall number | D-0139-2026 |
| Classification | Class III |
| FDA status | Ongoing |
| Origin on file | Malvern PA United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.