Prescription Drug Everolimus Recalled for Out-of-Specification Impurity
Endo USA, Inc. is recalling 935 cartons of Everolimus tablets (10 mg) nationwide due to out-of-specification impurity (IP-C). Affected lots: 550162801 (Exp. Nov 2025) and 550169801 (Exp. Jan 2026).
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 recalls are typically assigned scores of 1 or 2. No illnesses or injuries have been reported in the source text. The hazard is a quality specification failure (out-of-specification impurity), a manufacturing defect without reported patient harm. This is scored as Moderate (2) in accordance with the Class III classification and absence of reported illness.
Plain-English summary
Endo USA, Inc. is recalling 935 cartons of Everolimus tablets (10 mg) nationwide in the United States. The recall was initiated due to failed quality specifications, specifically because the product contains an out-of-specification level of impurity IP-C.
The affected lots are: Lot #550162801 (Expiration Date November 2025) and Lot #550169801 (Expiration Date January 2026). The product is manufactured by Par Pharmaceutical in Chestnut Ridge, New York.
Patients currently taking this medication should contact their healthcare provider or pharmacist to confirm whether they have received product from the affected lots. Affected patients should not stop taking their medication without first consulting their healthcare provider.
Consumers with affected product should discuss the recall with their healthcare provider or pharmacist. Healthcare providers and pharmacies should cease dispensing product from the affected lots immediately.
The recalled product
- Product
- EVEROLIMUS (EVEROLIMUS)
- Brand
- EVEROLIMUS
- Manufacturer
- Endo USA, Inc.
- Category
- Drug
- Hazard
- impurity
- out-of-specification
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 (4)
- Lot #: 550162801
- Exp. Date NOV-25
- 550169801
- Exp. Date JAN-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
- ModerateFDA Recalls Everolimus Tablets Due to 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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