Class III · Low risk Ongoing
Everolimus tablets 2.5 mg
Reason Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Everolimus tablets 10 mg
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
What was recalled
Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-128-91
- Recalling firm
- Endo USA, Inc.
- NDC code
- 49884-128-91
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0141-2026
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Everolimus recalls
See all
Class III · Low risk Ongoing
Everolimus tablets 7.5mg
Reason Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Class III · Low risk Ongoing
Everolimus tablets 5mg
Reason Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Class III · Low risk Ongoing
Everolimus tablets 5mg
Reason Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Class II · Moderate risk Terminated
Everolimus active pharmaceutical ingredient packaged in varying…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
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