Everolimus Recall: Endo 5 mg tablets
Announced 2026-05-20 · FDA
Endo USA, Inc. recalls Everolimus tablets 5 mg, 28-count cartons (4 blister strips of 7 tablets), Rx only. NDC 49884-125-91, Lot 550172301, Exp January 2026, manufactured by Par Pharmaceutical Chestnut Ridge, NY 10977, and distributed nationwide in the United States. The recall is due to out-of-specification impurity IP-C (Failed Impurities/Degradation Specifications). Approximately 1,041 cartons were distributed nationwide.
| Brand | Endo USA, Inc. |
|---|---|
| Product | 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 |
| Reason | Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. |
| Severity | low |
| Units affected | 34293 |
| Distribution | Nationwide within the United States |
| Agency | FDA |
| Recall / campaign no. | Lot #: 550172301, Exp. Date January 2026 |
WHAT YOU SHOULD DO
- Do not use Everolimus tablets from Lot 550172301.
- Contact your pharmacist or healthcare provider for guidance and possible replacement.
- If you have the recalled product, return it to the place of purchase or dispose of it according to local guidelines.
- For more information, contact Endo USA, Inc. or the FDA recall number 550172301.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.