Carvedilol Tablets recalled over manufacturing violations

Recall date

January 22, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Glenmark Pharmaceuticals Inc., USA recalls Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufacture…

Recall number

D-0215-2025

FDA classification

Class II

Brand / firm

Glenmark Pharmaceuticals Inc., USA

Sold / distributed

Nationwide in the U.S

Why it was recalled

CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured for Glenmark Pharmaceuticals, NJ.