FDA Recall D-0026-2026
Endo USA, Inc. · Malvern, PA
Class III Ongoing 251 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
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.
Recall record
- Recall number
D-0026-2026- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide within the United States
- Recall initiated
- 2025-09-05
- Classified by FDA Center
- 2025-10-16
- FDA published
- 2025-10-22
- Recalling firm
- Endo USA, Inc.
- Firm location
- Malvern, PA
Drug identification
- Brand name(s)
- EVEROLIMUS
- Generic name(s)
- EVEROLIMUS
- Manufacturer(s)
- Par Health USA, LLC
- NDC(s)
49884-119, 49884-125, 49884-127, 49884-128- Route(s)
- ORAL
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.