Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 550172301, Exp. Date January 2026
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0026-2026
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Sep 5, 2025
- FDA report date
- Oct 22, 2025
- Quantity
- 1,041 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Endo USA, Inc.
Original FDA data
Every field from FDA enforcement report D-0026-2026, exactly as published.
Show all FDA fields
- City
- Malvern
- State
- PA
- Status
- Ongoing
- Country
- United States
- Event ID
- 97557
- Address
- 9 Great Valley Pkwy
- Code information
- Lot #: 550172301, Exp. Date January 2026
- Postal code
- 19355-1304
- Report date
- Oct 22, 2025
- Product type
- Drugs
- Recall number
- D-0026-2026
- Classification
- Class III
- Recalling firm
- Endo USA, Inc.
- Product quantity
- 1,041 cartons
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Sep 5, 2025
- Initial firm notification
- Letter
- Center classification date
- Oct 16, 2025