FDA Drugs recall ·
Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips… recall
- Recall number
- D-0139-2026
- Date
- (initiated October 10, 2025)
- Company / brand
- Endo USA, Inc.
9 Great Valley Pkwy, Malvern, PA, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 6,655 cartons
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 550184901, 550185001, Exp. Date MAR-26; 550189901, 550190001, Exp. Date APR-26 550203901, 550205601, Exp. Date Jul-26
Distribution
Nationwide within the United States
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0139-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.