Endo USA, Inc.: Drug Recall
Recall #D-0142-2026 · 10/10/2025
Class III: Low Risk
Recall Details
- Recall Number
- D-0142-2026
- Classification
- Class III
- Product Type
- Drug
- Recalling Firm
- Endo USA, Inc.
- Status
- Ongoing
- Date Initiated
- 10/10/2025
- Location
- Malvern, PA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,035 cartons
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Product Description
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
Distribution Pattern
Nationwide within the United States
Other Recalls by Endo USA, Inc.
- Class III: Low Risk 10/10/2025
- Class III: Low Risk 10/10/2025
- Class III: Low Risk 10/10/2025
- Class III: Low Risk 09/05/2025
- Class I: Dangerous 12/20/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.