Major Pharmaceuticals recalled 26,628 cartons of Carvedilol Tablets on August 20, 2025. The recall stems from N-Nitroso Carvedilol Impurity-1 levels exceeding FDA limits. Consumers should stop using the product immediately and consult their healthcare provider.
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Consumers and healthcare providers should stop using this product immediately. Contact The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories or your healthcare provider for guidance. Notification method: Letter
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The recalled product is Carvedilol Tablets USP, 12.5 mg, packaged in 100-tablet cartons. The affected lot number is T05693, with an expiration date of March 2026. The product was distributed nationwide across the United States.
Testing revealed N-Nitroso Carvedilol Impurity-1 levels above the FDA-recommended limit of 4.0 ppm. This impurity can pose health risks if consumed in excess.
Consumers should stop using Carvedilol Tablets immediately. Contact Major Pharmaceuticals or your healthcare provider for guidance on the next steps.
For more information, contact The Harvard Drug Group LLC at [contact number not provided]. Visit the FDA website for further details at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0594-2025.
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