The Indian manufacturer of more than two dozen varieties of eyedrops that were subject to a U.S. safety warning has officially recalled the products. These eyedrops were sold by CVS Health, Target, Rite Aid, and other national retailers.
Kilitch Healthcare India issued the recall on Monday, and the Food and Drug Administration (FDA) published the notice on Wednesday. The FDA had already alerted U.S. stores last month to stop selling the over-the-counter drops.
The FDA advises consumers not to use the products due to the risk of vision loss or blindness.
FDA officials do not have the legal authority to force manufacturers to recall their products. Instead, they rely on companies to voluntarily recall. The FDA had recommended the manufacturer recall the eyedrops on October 25.
Mumbai-based Kilitch Healthcare stated that it has not received any reports of adverse events related to its products. The lubricating drops were distributed in the U.S. by Velocity Pharma and have expiration dates between November 2023 and September 2025.
The FDA had previously warned about unsanitary conditions and bacterial contamination at the factory where the drops were manufactured.
Agency records show no prior inspections for Kilitch Healthcare, suggesting that FDA officials may still be finalizing documentation from the inspection that triggered the latest recall.
The FDA is responsible for assuring the safety of foreign products shipped to the U.S., but it has struggled to keep pace with international pharmaceutical supply chains that increasingly begin in India.
The FDA has been working to make up for missed inspections during the COVID-19 pandemic. CVS Health has already stopped the sale of the recalled eyedrops and offers customers a full refund.
Target and Cardinal Health, another company selling the products, did not respond to inquiries.
Earlier this year, an outbreak of drug-resistant bacteria was linked to eyedrops from two different companies, EzriCare and Delsam Pharma. More than 80 people in the U.S. tested positive for eye infections from the bacteria, resulting in vision loss, eye removal, and death.
After the products were recalled in February, health inspectors found problems with the manufacturing and testing process at the plant in India’s Tamil Nadu state.