Endo USA, Inc. recalls Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufacture…
- Recall date
- October 10, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0142-2026
- FDA classification
- Class III
- Brand / firm
- Endo USA, Inc.
- Sold / distributed
- Nationwide within the United States
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-119-91
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