FDAFDA · Food and drugs·Recall number D-0026-2026
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
Published October 22, 2025 · Recall initiated: September 5, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Endo USA, Inc.
- Distributor
- Nationwide within the United States
- Lot
- Lot #: 550172301, Exp. Date January 2026
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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