Four eye ointments sold in stores including Walmart and CVS are being recalled because of a potential risk of eye infections or related harm, after U.S. investigators raised concerns about the potential lack of sterility.
The voluntary recall involves four over-the-counter products manufactured by Brassica Pharma, according to an announcement by the Food and Drug Administration on Monday.
Two are from Equate, a Walmart brand; one is a CVS Health brand; and another is an AACE Pharmaceuticals brand. They have expiration dates ranging from February 2024 to September 2025.
Brassica Pharma is a drug development and manufacturing company based in the Indian state of Maharashtra that supplies products to the United States, Europe, Asia and Africa, according to the company’s website. Brassica Pharma’s factory is in the city of Tarapur, about three hours north of Mumbai.
“The products are being recalled due to lack of sterility assurance at the facility noted during an inspection conducted by the Food and Drug Administration,” the announcement said. It added that, as of Feb. 16, the company had not received any reports of adverse reactions related to these products.
The products are intended to be sterile, the administrator said, because drugs applied to the eyes bypass some of the body’s natural defense systems.
Other eye products have been recalled in recent months.
In October, the F.D.A. advised consumers to stop using more than two dozen over-the-counter eyedrop products sold at stores including Target, CVS and Walmart after inspectors found unsanitary conditions at a manufacturing plant. Bacterial tests came back positive from critical drug production areas in the plant.
The manufacturer, Kilitch Healthcare, an Indian company also based in the state of Maharashtra, then voluntarily recalled the 27 eyedrop products. No adverse effects were reported at the time of the recall.
Early last year, the Centers for Disease Control and Prevention and the F.D.A. warned consumers to stop using two eyedrop products after they were tied to a drug-resistant bacteria strain found to have caused at least four deaths and vision loss in 14 patients.
Eyedrops are generally safe, according to experts, who recommend that people speak with their eye doctors to get recommendations for safe products.
