Glenmark, FDC recall products in US due to manufacturing issues: USFDA

Drug firms Glenmark Pharmaceuticals and FDC Ltd are recalling products in the US market due to manufacturing issues, according to the US Food and Drug Administration (USFDA). In its latest Enforcement Report, the US health regulator said a US-based subsidiary of Mumbai-headquartered Glenmark Pharmaceuticals is recalling a certain number of a generic hypertension medication in the US market.

New Jersey-based Glenmark Pharmaceuticals Inc, USA is recalling Carvediol tablets in strengths of 25 mg and 12.5 mg in the US, the US health regulator stated.

The company is recalling the product as "N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit".


The company initiated the Class II recall on January 22 this year.

USFDA said FDC Ltd is recalling 1,18,104 bottles of a medication for the treatment of glaucoma.

The drug firm is recalling the affected lot of Timolol Maleate ophthalmic solution USP produced at its Aurangabad-based plant, it added.

The recall is due to a "Defective Container", the USFDA stated.

"Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle," it added.

The company initiated the Class II recall on January 23, 2025.

As per the USFDA, a Class II recall is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.