Prescription drug recall for Everolimus tablets due to impurity specification failure
Endo USA, Inc. is recalling Everolimus 2.5 mg tablets nationwide because certain lots contain an out-of-specification impurity (IP-C). No illnesses or injuries have been reported.
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: FDA Class III recall with no reported illnesses, injuries, or deaths. The hazard is a chemical specification failure (out-of-spec impurity) without documented patient harm, making this a precautionary quality-control recall. Per the rubric, Class III recalls are typically scored 1-2.
Plain-English summary
Endo USA, Inc. is recalling Everolimus 2.5 mg tablets due to failed impurity specifications. The affected medication is distributed nationwide in cartons containing 28 tablets (4 blister strips of 7 tablets each), manufactured by Par Pharmaceutical in Chestnut Ridge, NY. Three specific lots are involved: Lot #550172201 (expiring January 2026), Lot #550184801 (expiring March 2026), and Lot #550204001 (expiring July 2026). Approximately 2,035 cartons have been distributed.
The recall was initiated because these lots failed to meet impurity specifications, specifically for impurity IP-C, a degradation product. Everolimus is a prescription immunosuppressant medication used to prevent organ rejection in transplant patients.
Patients who may have received Everolimus from the affected lots should contact their healthcare provider or pharmacist to determine if their supply is affected. Since Everolimus is a prescription medication requiring medical oversight, healthcare providers should be consulted before taking any action.
The recalled product
- Product
- EVEROLIMUS (EVEROLIMUS)
- Brand
- EVEROLIMUS
- Manufacturer
- Endo USA, Inc.
- Category
- Drug — Immunosuppressant
- Hazard
- impurity
- degradation
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.
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