Glenmark Pharmaceuticals and FDC Ltd are recalling a few drugs from the US market on account of manufacturing issues, as per the US Food and Drug Administration (USFDA). The Enforcement Report of the US health regulator mentions the recalls, including drugs for hypertension and glaucoma treatment.

Key Highlights:
Glenmark Pharmaceuticals Recall:

• New Jersey-based Glenmark Pharmaceuticals Inc., USA is recalling Carvedilol tablets in strengths of 25 mg and 12.5 mg.

• The recall is because of N-Nitroso Carvedilol I impurity (NNCI-I) content above USFDA recommended levels.

• The recall was a Class II, started on January 22, 2025.

FDC Ltd Recall:

• FDC Ltd is recalling 1,18,104 bottles of a glaucoma drug.

• Details about the exact manufacturing problem for the glaucoma drug have not been revealed yet.

USFDA Classification of Recalls:

• Class II recalls mean that exposure to the product can lead to temporary or medically reversible health effects, but there is a low risk of serious health effects.

• The recall points to ongoing scrutiny by the USFDA of pharmaceutical quality compliance of drugs shipped from India to the US.

Industry Experts' Statements:
USFDA Enforcement Report:"Carvedilol tablets are being recalled by Glenmark Pharmaceuticals because the level of impurity is beyond the limit prescribed, whereas FDC Ltd is recalling a large number of glaucoma medication."The recalls reiterate the need for strict quality control processes in pharmaceutical production. Both Glenmark and FDC Ltd need to fix the manufacturing issues and cooperate with USFDA standards to avoid future disruptions. The international pharmaceutical industry continues to come under closer regulatory scrutiny, particularly for drugs exported to highly regulated markets such as the US.