Everolimus 2.5 mg tablets recalled after an out of specification impurity result
Endo USA is recalling 2,035 cartons of Everolimus tablets 2.5 mg after results came back out of specification for impurity IP-C.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the FDA designated this Class III and the record cites a specification failure with no stated health consequence.
Plain-English summary
Everolimus tablets, 2.5 mg, in 28-tablet cartons containing four blister strips of seven tablets, manufactured by Par Pharmaceutical of Chestnut Ridge, New York, are being recalled for failed impurities and degradation specifications.
The product was out of specification for impurity IP-C.
The recall covers 2,035 cartons from lots 550172201 (expiring January 2026), 550184801 (expiring March 2026) and 550204001 (expiring July 2026), carrying NDC 49884-119-91. The product was distributed nationwide in the United States. The FDA has classified the recall as Class III, its least serious category.
The enforcement record names the impurity specification failure without describing a health consequence, and reports no injuries. Everolimus is a prescription medicine, so patients holding an affected lot should contact their pharmacy or prescriber about a replacement rather than stopping treatment on their own.
The recalled product
- Product
- EVEROLIMUS (EVEROLIMUS)
- Brand
- EVEROLIMUS
- Manufacturer
- Endo USA, Inc.
- Category
- Drug — Immunosuppressant
- Hazard
- impurity
- out-of-specification
- class-iii
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot #: 550172201
- Exp. Date JAN-26
- 550184801
- Exp. Date MAR-26
- 550204001
- Exp. Date JUL-26
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · EVEROLIMUS
- ModerateEverolimus tablets recalled after an out of specification impurity result
FDA (Drugs) · 2025-11-05
- ModerateEverolimus 7.5 mg tablets recalled after an out of specification impurity result
FDA (Drugs) · 2025-11-05
- ModerateEverolimus 10 mg tablets recalled after an out of specification impurity result
FDA (Drugs) · 2025-11-05
- ModerateEverolimus tablets recalled for out of specification impurity in one lot
FDA (Drugs) · 2025-10-22
Same category
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- ModerateQuality Choice Earwax Removal Kit Carbamide Peroxide Subpotent Drug Recall
FDA (Drugs) · 2026-07-22
- ModerateFamily Wellness Carbamide Peroxide Earwax Removal Kit Subpotent Drug
FDA (Drugs) · 2026-07-22
- ModerateLeader Carbamide Peroxide Earwax Removal Kit Recalled for Subpotency
FDA (Drugs) · 2026-07-22
- ModerateNystatin Cream Recall Due to Low Potency Test Results
FDA (Drugs) · 2026-07-22