Endo USA Recalls Everolimus Tablets for Out-of-Specification Impurity
Endo USA is recalling Everolimus 5mg tablets nationwide due to out-of-specification impurity levels. Affected consumers should consult their healthcare provider about their treatment plan.
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: This is an FDA Class III recall for a manufacturing quality defect (out-of-specification impurity). Class III recalls are typically scored 1 or 2. No illnesses or injuries have been reported. The hazard is a quality compliance issue rather than demonstrated harm, making this a precautionary recall.
Plain-English summary
Endo USA, Inc. is recalling Everolimus 5mg tablets nationwide. The recall affects 6,655 cartons distributed throughout the United States. The manufacturer initiated this recall after failing to meet quality specifications for impurity IP-C.
Everolimus is a prescription immunosuppressant medication used to prevent organ rejection in transplant patients and to treat certain types of cancer. The affected tablets are manufactured by Par Pharmaceutical, located in Chestnut Ridge, NY, and distributed by Endo USA, Inc.
Affected lots include 550184901 and 550185001 (expiration March 2026), 550189901 and 550190001 (expiration April 2026), and 550203901 and 550205601 (expiration July 2026). Healthcare providers should verify whether their patients have received product from these lots.
Consumers should contact their healthcare provider to discuss their treatment plan. Do not discontinue use of the medication without medical guidance, as stopping immunosuppressant therapy abruptly can have serious health consequences. Adverse effects can be reported to the FDA via MedWatch.
The recalled product
- Product
- EVEROLIMUS (EVEROLIMUS)
- Brand
- EVEROLIMUS
- Manufacturer
- Endo USA, Inc.
- Category
- Drug
- Hazard
- impurity
- 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 (8)
- Lot #: 550184901
- 550185001
- Exp. Date MAR-26
- 550189901
- 550190001
- Exp. Date APR-26 550203901
- 550205601
- Exp. Date Jul-26
Distribution
Distributed nationwide across the United States.
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