FDA Recalls Everolimus Tablets Due to Out-of-Specification Impurity
Endo USA is recalling 1,866 cartons of Everolimus 7.5mg tablets nationwide due to out-of-specification impurity levels in affected lots.
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 out-of-specification impurity and no reported adverse effects. Class III recalls typically score 1–2 per the rubric. This manufacturing specification failure places it at Moderate (2) rather than Low (1).
Plain-English summary
Endo USA, Inc. is recalling 1,866 cartons of Everolimus 7.5mg tablets distributed nationwide in the United States. The tablets are failing manufacturing specifications for impurity IP-C.
The affected lot numbers are 550167301, 550167401 (expiration date November 2025); 550185101 (expiration date March 2026); and 550205701 (expiration date July 2026). Patients should check their medication against these lot numbers and expiration dates.
Patients who have received tablets matching the affected lots should contact their healthcare provider for guidance regarding their medication. Do not discontinue use without consulting your doctor, as Everolimus is a prescription immunosuppressant used in transplant and other serious conditions.
The recalled product
- Product
- EVEROLIMUS (EVEROLIMUS)
- Brand
- EVEROLIMUS
- Manufacturer
- Endo USA, Inc.
- Category
- Drug — Immunosuppressant
- Hazard
- manufacturing-defect
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 (7)
- Lot #: 550167301
- 550167401
- Exp. Date NOV-25
- 550185101
- Exp. Date MAR-26
- 550205701
- Exp. Date JUL-26
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · EVEROLIMUS
- ModeratePrescription drug recall for Everolimus tablets due to impurity specification failure
FDA (Drugs) · 2025-11-05
- ModerateEndo USA Recalls Everolimus Tablets for Out-of-Specification Impurity
FDA (Drugs) · 2025-11-05
- ModeratePrescription Drug Everolimus Recalled for Out-of-Specification Impurity
FDA (Drugs) · 2025-11-05
- ModeratePrescription Drug Recall: Everolimus Tablets Fail Impurity Specification
FDA (Drugs) · 2025-10-22
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