Recalls / Class III
Class IIID-0026-2026
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
- Brand name
- Everolimus
- Generic name
- Everolimus
- Active ingredient
- Everolimus
- Route
- Oral
- NDCs
- 49884-119, 49884-125, 49884-127, 49884-128
- FDA application
- ANDA207934
- Affected lot / code info
- Lot #: 550172301, Exp. Date January 2026
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Recalling firm
- Firm
- Endo USA, Inc.
- Manufacturer
- Par Health USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 9 Great Valley Pkwy, Malvern, Pennsylvania 19355-1304
Distribution
- Quantity
- 1,041 cartons
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2025-09-05
- FDA classified
- 2025-10-16
- Posted by FDA
- 2025-10-22
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0026-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.