FDAFDA · Food and drugs·Recall number D-0594-2025
Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, 46268, USA, NDC 0904-7307-61
Published August 27, 2025 · Recall initiated: August 20, 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
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Distributor
- Product was distributed nationwide within the United States.
- Lot
- Lot #: T05693, Exp. Date 03/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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