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

FDA recall notice · announced October 22, 2025 · Endo

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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 for recall

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

Notes

Distribution: Nationwide within the United States
Lot/code information: Lot #: 550172301, Exp. Date January 2026
Quantity: 1,041 cartons
Status: Ongoing
Products in this recall event:
- 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 (D-0026-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.