Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05.

Class I - Dangerous

💊 Drugs Recalled: February 28, 2025 Glenmark Pharmaceuticals Inc., USA Prescription Drugs Nationwide

What Should You Do?

Check if you have this product:
Lot, expiry: Lots 19231107, 19231114, 19231152, Exp Feb-25; Lot 19234866, Exp Jan-26
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Glenmark Pharmaceuticals Inc., USA
Reason for Recall:: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05.