Class III · Low risk
Everolimus tablets 2.5 mg
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Everolimus tablets 5mg
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.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
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
Affected NDC
49884-0125-91
Compare with the code on your package — it is the most precise check available.
Drug: Everolimus
- Recalling firm
- Endo USA, Inc.
- NDC code
- 49884-125-91
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0139-2026 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
Other Everolimus recalls
See all
Class III · Low risk
Everolimus tablets 10 mg
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Class III · Low risk
Everolimus tablets 7.5mg
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Class III · Low risk
Everolimus tablets 5mg
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Class II · Moderate risk
Everolimus active pharmaceutical ingredient packaged in varying…
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.
Other recalls by Endo USA, Inc.
All 2025 recalls
Class II · Moderate risk
Buprenorphine Hydrochloride
Crystallization; identified as Buprenorphine free base
Class III · Low risk
Everolimus tablets 2.5 mg
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Class III · Low risk
Everolimus tablets 10 mg
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Class III · Low risk
Everolimus tablets 7.5mg
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
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