Everolimus
FDA Recall NDC 49884-128
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
The FDA has identified 5 recorded enforcement report(s) associated with Everolimus (NDC 49884-128). A significant event, classified as Class III, was initiated on Oct 10, 2025 by Par Health Usa, Llc. The reported reason for this action was: "Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
October 2025 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Ongoing
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Oct 10, 2025
Nov 05, 2025
1,866 cartons
Recall Profile & Regulatory Data
Event ID
97866
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Endo USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
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
Batch or Lot Expiration Information
Lot# : 550167301, 550167401, Exp. Date NOV-25; 550185101, Exp. Date MAR-26; 550205701, Exp. Date JUL-26
Affected Packages Involved in this Recall
49884-119-52Product
49884-119-91Product
49884-125-52Product
49884-125-91Product
49884-127-52Product
49884-127-91Product
49884-128-52Product
49884-128-91Product
October 2025 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Ongoing
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Oct 10, 2025
Nov 05, 2025
2,035 cartons
Recall Profile & Regulatory Data
Event ID
97866
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Endo USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
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
Batch or Lot Expiration Information
Lot# : 550172201, Exp. Date JAN-26; 550184801, Exp. Date MAR-26; 550204001, Exp. Date JUL-26
Affected Packages Involved in this Recall
49884-119-52Product
49884-119-91Product
49884-125-52Product
49884-125-91Product
49884-127-52Product
49884-127-91Product
49884-128-52Product
49884-128-91Product
October 2025 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Ongoing
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Oct 10, 2025
Nov 05, 2025
6,655 cartons
Recall Profile & Regulatory Data
Event ID
97866
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Endo USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
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
Batch or Lot Expiration Information
Lot# : 550184901, 550185001, Exp. Date MAR-26; 550189901, 550190001, Exp. Date APR-26 550203901, 550205601, Exp. Date Jul-26
Affected Packages Involved in this Recall
49884-119-52Product
49884-119-91Product
49884-125-52Product
49884-125-91Product
49884-127-52Product
49884-127-91Product
49884-128-52Product
49884-128-91Product
October 2025 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Ongoing
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Oct 10, 2025
Nov 05, 2025
935 cartons
Recall Profile & Regulatory Data
Event ID
97866
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Endo USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
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
Batch or Lot Expiration Information
Lot# : 550162801, Exp. Date NOV-25; 550169801, Exp. Date JAN-26
Affected Packages Involved in this Recall
49884-119-52Product
49884-119-91Product
49884-125-52Product
49884-125-91Product
49884-127-52Product
49884-127-91Product
49884-128-52Product
49884-128-91Product
September 2025 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Ongoing
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Sep 05, 2025
Oct 22, 2025
1,041 cartons
Recall Profile & Regulatory Data
Event ID
97557
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Endo USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
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
Batch or Lot Expiration Information
Lot# : 550172301, Exp. Date January 2026
Affected Packages Involved in this Recall
49884-119-52Product
49884-119-91Product
49884-125-52Product
49884-125-91Product
49884-127-52Product
49884-127-91Product
49884-128-52Product
49884-128-91Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
