Class III
Ongoing
Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-127-91
This recall is currently active, issued November 5, 2025. It was issued by Endo Usa, Inc..
- Company
- Endo Usa, Inc.
- Recall Initiated
- October 10, 2025
- Posted
- November 5, 2025
- Recall Number
- D-0140-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1,866 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 #: 550167301, 550167401, Exp. Date NOV-25; 550185101, Exp. Date MAR-26; 550205701, Exp. Date JUL-26
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