FDA issues warning for 26 eyedrops due to risk of infection, blindness

The Food and Drug Administration has issued warnings for 26 over-the-counter eye care products because of the potential for infection that could lead to vision loss or even blindness.

The products carry the CVS Health, Rite Aid, Leader (Cardinal Health), Rugby (Cardinal Health) and Target Up&Up labels — as well as Velocity Pharma, which retailers have identified as the eye drops’ supplier. The FDA provided a list of the products on its website, and encouraged health-care professionals and consumers to report negative effects or quality problems. The agency has not received any reports about eye infections.

The FDA has advised the manufacturer to recall the eyedrops after its inspectors discovered “insanitary conditions in the manufacturing facility,” according to a news release Friday. There were also “positive bacterial test results from environmental sampling of critical drug production areas in the facility,” the FDA added.

Though CVS, Rite Aid and Target are pulling the products from store shelves and websites, they might still be available for purchase, the FDA cautioned.

At CVS, a spokeswoman said the drops have been discontinued online and in-store, and that they can be returned for a full refund. “We’re committed to ensuring the products we offer are safe, work as intended and satisfy customers, and are fully cooperating with the FDA on this matter,” she said.

A Rite Aid spokeswoman said the retailer had removed the products from its shelves.

A spokeswoman for Cardinal Health said the company immediately put on hold all of the eye drop products the FDA flagged as unsafe and is initiating a recall of the Rugby Laboratories and Cardinal Health Leader branded eye drop products. She added that it is working with Velocity Pharma to “to gain additional insight regarding the unsanitary conditions identified by the FDA at the manufacturing facility.”

Velocity Pharma did not immediately respond to a request for comment on Monday.

Earlier this year, several other eye drop brands were recalled over concerns about whether they were sterile. In March, the Purely Soothing, 15% MSM Drops were recalled over concerns they could be contaminated. A month earlier, the national Centers for Disease Control and Prevention urged consumers to stop using EzriCare Artificial Tears, a preservative-free eye drop product suspected of causing an outbreak of 55 serious bacterial infections in 12 states. At least five of them resulted in permanent vision loss and at least one death.

Symptoms of eye infection include discharge from eye, pain or discomfort, redness, and a feeling that something foreign is in the eye, experts have previously told The Washington Post. If symptoms do not improve or get worse, seek medical care.

Here are the recalled products:

CVS Health

• Lubricant Eye Drops 15 ml (single pack)
• Lubricant Eye Drops 15 ml (twin pack)
• Lubricant Gel Drops 15 ml (single pack)
• Lubricant Gel Drops 15 ml (twin pack)
• Multi-Action Relief Drops 15 ml
• Lubricating Gel drops 10 ml
• Lubricant Eye Drops 10 ml (single pack)
• Lubricant Eye Drops 10 ml (twin pack)
• Mild Moderate Lubricating Eye Drops 15 ml (single pack)

Rugby (Cardinal Health)

• Lubricating Tears Eye Drops 15 ml
• Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15 ml

Leader (Cardinal Health)

• Dry Eye Relief 10 ml
• Lubricant Eye Drops 15 ml (single pack)
• Lubricant Eye Drops 15 ml (twin pack)
• Dry Eye Relief 15 ml
• Eye Irritation Relief 15 ml

Rite Aid

• Lubricant Eye Drops 15 ml (twin pack)
• Lubricant Eye Drops 10 ml (twin pack)
• Gentle Lubricant Gel Eye Drops 15 ml
• Lubricant Gel Drops 15 ml
• Lubricating Gel Drops 10 ml
• Multi-Action Relief Drops 15 ml

Target

• Up&Up Dry Eye Relief Lubricant Eye Drops 30 ml
• Up&Up Extreme Relief Dry Eye 15 ml (single pack)
• Up&Up Extreme Relief Dry Eye 30 ml (twin pack)

Velocity Pharma

• Lubricant Eye Drop 10 ml (triple pack)

Marlene Cimons contributed to this report