Everolimus tablets recalled after an out of specification impurity result
Endo USA is recalling 6,655 cartons of Everolimus tablets 5 mg after results came back out of specification for impurity IP-C.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, 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 6,655 cartons across lots including 550184901 and 550185001 (expiring March 2026) and 550189901 and 550190001 (expiring April 2026), carrying NDC 49884-125-91. 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 tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-125-91
- Manufacturer
- Endo USA, Inc.
- Category
- Drug — Immunosuppressant
- Affected units
- 6,655
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.
Part of a larger recall action
This product is one of 4 recalled by Endo USA, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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