FDC recalls more than 60000 bottles of glaucoma medication in US

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-05-10T12:30:53+05:30 | Updated On 10 May 2025 12:30 PM IST

FDC recalls over 60000 bottles of Timolol Maleate Ophthalmic Solution in US

Mumbai: Mumbai-headquartered drug firm FDC Ltd is recalling 60,428 bottles of Timolol Maleate Ophthalmic Solution in the US market over manufacturing issue, as per the US Food and Drug Administration's latest Enforcement Report.

Timolol Maleate Ophthalmic Solution is used for the treatment of glaucoma, a condition that causes damage to the optic nerve due to increased pressure in the eye.

"The company is recalling the affected lot due to "Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle," the USFDA said.

The drugmaker initiated the Class II nationwide (US) recall on April 18 this year, PTI reported.

Read also: Recall of Medtronic embolization devices classified as most serious by USFDA

As per the USFDA, a Class II recall is initiated in a situation in which the 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.

This is not the first time FDC has faced such an issue. Last year, Medical Dialogues reported that the company had recalled 155,232 bottles of the same eye medication from the US market.

FDCFDC newsrecallglaucoma drugglaucomatimolol maleate ophthalmic solution

Source : with inputs

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751