Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-127-91

FDA recall notice · announced November 5, 2025 · Endo

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

The product

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 #: 550167301, 550167401, Exp. Date NOV-25; 550185101, Exp. Date MAR-26; 550205701, Exp. Date JUL-26
Quantity: 1,866 cartons
Status: Ongoing
Products in this recall event:
- Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-119-91 (D-0142-2026)
- Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-128-91 (D-0141-2026)
- 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 (D-0139-2026)
- Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-127-91 (D-0140-2026)

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