Ezetimibe and Simvastatin Tablets recall: Impurity Out of Spec
Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma…
Why was Ezetimibe and Simvastatin Tablets recalled?
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.
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 #: 17240195, Exp 01/31/2026.
- Product
- Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma…
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Quantity
- 6,759 Con - 90 bottle pack
- Distribution
- Nationwide USA and PR
- Recall date
- June 18, 2025
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (drug)