D-0026-2026 Class III Ongoing
FDA drug recall D-0026-2026 was initiated by Endo USA, Inc. on September 5, 2025 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. The recall status is ongoing. Affected quantity: 1,041 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- October 22, 2025
- Initiation Date
- September 5, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,041 cartons
Product Description
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.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 550172301, Exp. Date January 2026