Endo USA, Inc. recalls Everolimus tablets 5mg
- Recalling company
- Endo USA, Inc.
- 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.
- Classification
- Class III – not likely to cause adverse health consequences
- Recall date
- Oct 10, 2025
- Reported
- Nov 5, 2025
- Distribution
- Nationwide within the United States
- Status
- Ongoing
- Quantity
- 6,655 cartons
- Lot / codes
- Lot #: 550184901, 550185001, Exp. Date MAR-26; 550189901, 550190001, Exp. Date APR-26 550203901, 550205601, Exp. Date Jul-26
- Company location
- Malvern, PA
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0139-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0139-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.