Endo recalls everolimus 5mg tablets because a impurity level was out of specification
Tests found that the level of an impurity called IP-C in these everolimus tablets was outside the allowed limit, so the tablets failed their quality requirements.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- 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
- Company
- Endo USA, Inc.
- Hazard
- Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
- Units
- 1,041 cartons
- Where sold
- Nationwide within the United States
- FDA classification
- Class III · Ongoing
- Classified by FDA
- October 16, 2025
- Recall started
- September 5, 2025
- FDA enforcement report
- October 22, 2025
- Identifiers
- Codes: Lot #: 550172301, Exp. Date January 2026
- FDA recall number: D-0026-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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 for recall
- Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
- Classification
- Class III (Ongoing)
- Distribution
- Nationwide within the United States
- Quantity
- 1,041 cartons
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