Indian manufacturer recalls eyedrops previously cited in FDA warning

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The Indian manufacturer of more than a number of eyedrops subject to a U.S. safety warning has officially recalled the products

WASHINGTON — The Indian manufacturer of more than two dozen varieties of eyedrops subject to a U.S. safety warning has officially recalled the products, which 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 published the notice Wednesday. The recall is something of a formality, since the FDA had already alerted U.S. stores last month to stop selling the over-the-counter drops.

Consumers should not use the products due to the risk of vision loss or blindness, the FDA said.

FDA officials don't have the legal authority to force manufacturers to recall their products, and instead rely on companies to “voluntarily” do so. The FDA previously stated it recommended the manufacturer recall the eyedrops on Oct. 25.

Mumbai-based Kilitch Healthcare said 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, based in Farmingdale, N.Y., and carry expiration dates between November 2023 and September 2025.

The FDA said in its initial warning that agency inspectors found unsanitary conditions and bacterial contamination at the factory where the drops were manufactured.

Agency records show no prior inspections for Kilitch Healthcare. FDA only publishes inspections to its online database after they have been completed and processed. That suggests agency officials may still be finalizing documentation from the inspection that triggered the latest recall.

The FDA is responsible for assuring the safety of