Endo recalls everolimus tablets over impurity level above allowed limit
The tablets tested out of specification for an impurity called IP-C, meaning the amount found did not meet the required limits for the medicine.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- Product
- Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-127-91; Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-119-91; Everolimus tablets 10…
- Company
- Endo USA, Inc.
- Hazard
- Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
- Units
- 1,866 cartons; 2,035 cartons; 935 cartons
- Where sold
- Nationwide within the United States
- FDA classification
- Class III · Ongoing
- Classified by FDA
- October 29, 2025
- Recall started
- October 10, 2025
- FDA enforcement report
- November 5, 2025
- Identifiers
- Codes: Lot #: 550167301, 550167401, Exp. Date NOV-25; 550185101, Exp. Date MAR-26; 550205701, Exp. Date JUL-26
- FDA recall number: D-0140-2026
- Codes: Lot #: 550172201, Exp. Date JAN-26; 550184801, Exp. Date MAR-26; 550204001, Exp. Date JUL-26
- FDA recall number: D-0142-2026
- Codes: Lot #: 550162801, Exp. Date NOV-25; 550169801, Exp. Date JAN-26
- FDA recall number: D-0141-2026
- Codes: Lot #: 550184901, 550185001, Exp. Date MAR-26; 550189901, 550190001, Exp. Date APR-26 550203901, 550205601, Exp. Date Jul-26
- FDA recall number: D-0139-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- Product
- Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-127-91 | Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-119-91 | 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 | 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 for recall
- Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
- Classification
- Class III (Ongoing)
- Distribution
- Nationwide within the United States
- Quantity
- 1,866 cartons; 2,035 cartons; 935 cartons; 6,655 cartons
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