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Carvedilol

FDA recalls

10 rows

DateCompany and reasonClass
Aug 19, 2025The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm		Class II · Ongoing
Aug 6, 2025Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.		Class II · Ongoing
Aug 5, 2025Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm		Class II · Ongoing
Mar 12, 2025Glenmark Pharmaceuticals Inc., USA
CGMP Deviations		Class II · Ongoing
Feb 27, 2025Glenmark Pharmaceuticals Inc., USA
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit		Class II · Ongoing
Jan 21, 2025Glenmark Pharmaceuticals Inc., USA
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.		Class II · Ongoing
Nov 14, 2021Aurobindo Pharma USA Inc.
Failed Impurities/Degradation Specifications		Class III · Terminated
Aug 12, 2021Zydus Pharmaceuticals (USA) Inc
Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle		Class II · Terminated
Apr 24, 2019Zydus Pharmaceuticals USA Inc
Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg		Class II · Terminated
Apr 21, 2019Zydus Pharmaceuticals USA Inc
Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of Carvedilol tablets 3.125mg.		Class III · Terminated

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Sources: CMS Medicare Part D Prescribers 2024; CMS Open Payments 2025 (general payments; a payment is not evidence of wrongdoing); FDA enforcement reports (openFDA).