Major Recalls: Glenmark and FDC Tackle USFDA Warnings

Glenmark Pharmaceuticals and FDC Ltd are withdrawing products in the US due to manufacturing problems, as per USFDA reports. Glenmark is recalling hypertension medication due to impurity issues, while FDC is retracting glaucoma treatment due to defective containers. Both are classified under Class II recalls.

Drug manufacturers Glenmark Pharmaceuticals and FDC Ltd are pulling back products from the United States market due to manufacturing complications, according to the US Food and Drug Administration (USFDA).

The US health regulator disclosed in its latest Enforcement Report that Glenmark Pharmaceuticals' US subsidiary is withdrawing certain batches of a generic hypertension drug.

Headquartered in New Jersey, Glenmark Pharmaceuticals Inc, USA is recalling Carvediol tablets in 25 mg and 12.5 mg formulations after identifying unacceptable levels of NNCI-I impurities.

This Class II recall was initiated on January 22, indicating that while the use of the product might lead to temporary or medically reversible adverse health effects, serious health consequences remain unlikely.

Meanwhile, FDC Ltd is reclaiming 1,18,104 bottles of Timolol Maleate ophthalmic solution due to defective container issues.

According to the USFDA, the defect involves the spike of the cap becoming lodged in the product bottle's nozzle, preventing the solution from being dispensed. The company began its Class II recall on January 23, 2025.

(With inputs from agencies.)