Reported Oct 22, 2025 · Ongoing
Everolimus tablets 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 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only
- Manufactured by
Par Pharmaceutical Chestnut RidgeNY 10977NDC 49884-125-91
- Lot codes and dates
Lot #: 550172301Exp. Date January 2026
- Amount recalled
- 1,041 cartons
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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