Everolimus tablets 5mg recall
FDA recall D-0139-2026 · initiated Oct 10, 2025
Endo USA, Inc. recalled Everolimus tablets 5mg in Oct 2025 — an FDA Class III recall (D-0139-2026) because Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 6,655 cartons
Details
- Product
- 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
- Recalling company
- Endo Pharms
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Oct 10, 2025
- FDA report date
- Nov 5, 2025
Frequently asked
- Was Everolimus tablets 5mg recalled?
- Endo USA, Inc. recalled Everolimus tablets 5mg in Oct 2025 — an FDA Class III recall (D-0139-2026) because Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Everolimus tablets 5mg recalled?
- Per the FDA enforcement record, the reason for recall D-0139-2026 was: Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
- Is a recalled Everolimus tablets 5mg dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Everolimus tablets 5mg are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: 550184901, 550185001, Exp. Date MAR-26; 550189901, 550190001, Exp. Date APR-26 550203901, 550205601, Exp. Date Jul-26. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0139-2026.