Reported Nov 5, 2025 · Ongoing
Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured…
Endo USA, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Endo USA, Inc. · 9 Great Valley Pkwy · Malvern, PA · 19355-1304
Is this the product you have?
- Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only
- Manufactured byPar Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-127-91
- Lot codes and dates
Lot #: 550167301550167401Exp. Date NOV-25550185101Exp. Date MAR-26550205701Exp. Date JUL-26
- Amount recalled
- 1,866 cartons
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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