FDA Drug recall D-0139-2026
Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutica…
- FDA Drug
- Class III
- ongoing
- Published 2025-11-05
On 2025-11-05 the FDA classified a Class III recall of Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutica… by Endo Usa, citing failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0139-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-10-10 |
| Published | 2025-11-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Endo Usa |
| Distribution | US |
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
Reason
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Identifiers
| code_info | Lot #: 550184901, 550185001, Exp. Date MAR-26; 550189901, 550190001, Exp. Date APR-26 550203901, 550205601, Exp. Date Jul-26 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0139-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.