Reuters found that, based on the product packaging, most of the recalled products were manufactured at the Assam state facility in Kokjhar village. Reuters could not independently verify whether the 332 batches cited by regulators were related only to the 11 identified brands in the recall notice or included additional brands.
The affected batches could translate into hundreds of thousands of eye-drop bottles, according to industry experts, who declined to be identified because they were not authorised to speak publicly.
Ophthalmology contributes about 3 per cent of Sun Pharma’s domestic revenue, according to its 2025-26 annual report. It is also one of its key areas for the United States.
The company reported a drop in second-quarter profit on Friday (Oct 30) weighed down by a one-time charge related to its acquisition of US-based Organon.
The eye product recall coincided with a patient-safety advisory issued in June by the All India Ophthalmological Society (AIOS), an independent body of eye specialists, warning that certain batches of Predmet eye drops appeared to be contaminated.
“There were some adverse cases of infections reported in patients who used Predmet and we got sealed bottles investigated and found it was contaminated,” Santosh Honavar, a doctor and secretary of AIOS, told Reuters, adding that Sun Pharma had also recalled those Predmet drops.
Sun Pharma did not respond to Reuters’ request for comment on the AIOS advisory.
The regulators issued a show-cause notice to Sun Pharma on Aug 10, citing the quality management system failures, the documents showed.
Dissatisfied with the company’s response, the regulators ordered a halt to the manufacturing, sale and distribution of all ophthalmic products from the facility.
Indian regulators did not respond to Reuters’ requests for comment. The agency did not issue a public health alert after the recall.
It is not the first time Sun Pharma’s sterile manufacturing facilities have faced regulatory scrutiny. Last year, the US FDA halted the company’s shipments from Gujarat’s Halol plant after inspectors cited shortcomings in contamination controls.
