FDA (Drugs) recall action 96162
The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
The agency’s own wording, quoted from the enforcement report.
Glenmark Pharmaceuticals is recalling Carvedilol 25 mg tablets nationwide due to a manufacturing quality issue with impurity levels exceeding FDA recommended limits. Multiple lot numbers and expiration dates from February 2025 through February 2026 are affected.
Glenmark Pharmaceuticals is recalling carvedilol tablets nationwide due to N-nitroso carvedilol I (NNCI-I), a carcinogenic impurity found in certain lots. The impurity exceeds FDA safety limits.