FDAFDA · Food and drugs·Recall number D-0587-2025
Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430, NDC 68462-164-05
Published August 20, 2025 · Recall initiated: August 6, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CARVEDILOL
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Distributor
- Nationwide within the USA
- UPC
- 0368462162019
- Lot
- Lot #: 17241257, 17241258, 17241279, Exp. Date 06/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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