Endo USA, Inc. recalled 1,041 cartons of Everolimus 5mg tablets nationwide in the United States due to an impurity IP-C out of specification. The impurity IP-C is out of specification in the drug product. Patients and healthcare providers should stop using this product immediately and contact Endo USA or their healthcare provider for guidance.
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Consumers and healthcare providers should stop using this product immediately. Contact Endo USA, Inc. or your healthcare provider for guidance. Notification method: Letter
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Everolimus is an immunosuppressant medication used to prevent organ rejection in transplant patients. The 5mg tablet is prescription-only and distributed nationwide in the United States.
The product contains an impurity (IP-C) out of specification. This could affect safety and efficacy for patients taking the recalled tablets.
This recall is not described as part of a broader industry pattern in the provided information.
Patients may need to switch medications under medical supervision. The recall could disrupt treatment plans and requires prompt action by providers and patients.
NDC, lot number, and expiration are on the carton and blister-pack labeling.
Recall processes for refunds/replacements typically follow internal company timelines and FDA guidance; exact duration not specified.
Keep the recall notice, the product packaging, and any correspondence with Endo USA. Document batch/lot, NDC, and expiration for records.
Cartons: 1,041. Product: Everolimus 5mg tablets. NDC: 49884-125-91. Lot: 550172301. Expiration: January 2026. Pack size: 28 tablets per carton (4 blister strips x 7 tablets). Rx only. Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977. Sold nationwide within the United States. Recall date: 2025-09-05. Status: ACTIVE.
No injuries or incidents have been reported.
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