Class III
Ongoing
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
This recall is currently active, issued October 22, 2025. It was issued by Endo Usa, Inc..
- Company
- Endo Usa, Inc.
- Recall Initiated
- September 5, 2025
- Posted
- October 22, 2025
- Recall Number
- D-0026-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1,041 cartons
- Firm Location
- Malvern, PA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Distribution
Nationwide within the United States
Lot / Code Info
Lot #: 550172301, Exp. Date January 2026
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