FDC Ltd Recalls Over 60,000 Bottles of Ophthalmic Solution in US

FDC Ltd, a drug company from Mumbai, has had to recall more than 60,000 bottles of Timolol Maleate Ophthalmic Solution USP across the US. The trouble started when they found out the bottles were faulty the cap’s spike was getting jammed in the nozzle, making it impossible to squeeze out the eye drops. These drops are important for folks with glaucoma to keep their eye pressure in check. The recall began on April 25, 2025, after the US Food and Drug Administration (USFDA) flagged the issue.

The USFDA labeled this a Class II recall, which means there’s a slim chance it could cause minor, temporary health problems, but nothing too serious. The defective bottles were made at FDC’s plant in Aurangabad, India. This isn’t FDC’s first rodeo with this problem—just a few months ago, in January 2025, they pulled over 118,000 bottles for the same reason.

India’s pharmaceutical industry is a big deal, churning out about 20% of the world’s generic drugs. But lately, it’s been hitting some rough patches, especially in the US, where Indian companies ship billions of dollars’ worth of medicines every year. Other big names like Glenmark Pharmaceuticals and Dr. Reddy’s Laboratories have also had to recall products because of things like impurities or manufacturing mistakes. It’s a reminder that even the “pharmacy of the world” has to stay on its toes.

With the USFDA keeping a sharp eye and sometimes shutting down factories that don’t measure up, Indian drugmakers are under pressure to tighten their quality controls. Experts say better regulations and more rigorous testing could help keep India’s good name in the global drug market.

FDC is sorting out the mess but hasn’t said much publicly. If you’ve got these eye drops and they’re not working right, give your doctor or pharmacist a call. This whole thing shows how tough it can be to make medicines that are both affordable and totally reliable for people everywhere.