Recalls / Class III
Class IIID-0139-2026
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 #: 550184901, 550185001, Exp. Date MAR-26; 550189901, 550190001, Exp. Date APR-26 550203901, 550205601, Exp. Date Jul-26
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, N/A, Malvern, Pennsylvania 19355-1304
Distribution
- Quantity
- 6,655 cartons
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2025-10-10
- FDA classified
- 2025-10-29
- Posted by FDA
- 2025-11-05
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0139-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.