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CARVEDILOL Recalls

4 recalls found for CARVEDILOL. Check current safety alerts and related brands before using affected products.

Active recalls: 4
Pages: 1

Health & Personal Care

HIGH

FDA DRUG

Carvedilol Tablets 12.5 mg Recall Expanded for NNCI Impurity Above FDA Limit (2025)

The FDA recalls 26,628 cartons of Carvedilol Tablets USP 12.5 mg distributed nationwide. The product fails CGMP standards due to NNCI impurity exceeding FDA limits. Stop using and contact The Harvard Drug Group LLC and Rugby Laboratories for guidance.

Aug 20, 2025

Major Pharmaceuticals

CGMP Deviations:

Health & Personal Care

HIGH

FDA DRUG

Glenmark Carvedilol 25 mg Recall for Nitrosamine Impurity Affects 4,800 Bottles (2025)

CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.

Aug 7, 2025

Glenmark Pharmaceuticals

CGMP Deviations:

Health & Personal Care

HIGH

FDA DRUG

Glenmark Carvedilol 3.125 mg Recall for Nitrosamine Impurity Affects 44,328 Bottles (2025)

CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.

Aug 7, 2025

Glenmark Pharmaceuticals

CGMP Deviations:

Health & Personal Care

HIGH

FDA DRUG

Glenmark Carvedilol 25 mg Recall Expands Over NNCI Impurity Above FDA Limit in 14,976 Bottles

CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

Aug 6, 2025

CARVEDILOL

CGMP Deviations:

Brand Statistics

Total Recalls

Pages

CARVEDILOL Recalls

Carvedilol Tablets 12.5 mg Recall Expanded for NNCI Impurity Above FDA Limit (2025)

Glenmark Carvedilol 25 mg Recall for Nitrosamine Impurity Affects 4,800 Bottles (2025)

Glenmark Carvedilol 3.125 mg Recall for Nitrosamine Impurity Affects 44,328 Bottles (2025)

Glenmark Carvedilol 25 mg Recall Expands Over NNCI Impurity Above FDA Limit in 14,976 Bottles

Brand Statistics

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