FDAHealthOctober 10, 2025
Endo USA, Inc. — 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
⚠️ Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- October 10, 2025
Nationwide within the United States
What's affected?
- 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
- Brand
- EVEROLIMUS
- Lot code
- 550184901
Additional details
Lot #: 550184901, 550185001, Exp. Date MAR-26; 550189901, 550190001, Exp. Date APR-26 550203901, 550205601, Exp. Date Jul-26
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 6,655 cartons.
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