Carvedilol Tablets USP 25 mg recall: Impurity Out of Spec
Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals…
Why was Carvedilol Tablets USP 25 mg recalled?
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
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, expiry: Lots 19231107, 19231114, 19231152, Exp Feb-25; Lot 19234866, Exp Jan-26
- Product
- Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals…
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Quantity
- 18,696 bottles
- Distribution
- U.S. Nationwide
- Recall date
- June 4, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)