Everolimus tablets 2.5 mg recall: Impurity Out of Spec
Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical…
Why was Everolimus tablets 2.5 mg recalled?
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 550172201, Exp. Date JAN-26; 550184801, Exp. Date MAR-26; 550204001, Exp. Date JUL-26
- Product
- Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical…
- Recalling firm
- Endo USA, Inc.
- Quantity
- 2,035 cartons
- Distribution
- Nationwide within the United States
- Recall date
- November 5, 2025
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (drug)