EzriCare and Delsam Eye Drops and Ointment Recalled Due to Potential Bacterial Contamination

The recall of certain artificial tears products made by Global Pharma Healthcare has expanded to include an eye ointment. Some people have lost their vision permanently, and one person has died.

By Catherine Roberts

Published February 3, 2023 | Updated February 23, 2023

Artificial Tears Lubricant Eye Drops from EzriCare

On Feb. 2, 2023, two eye drop products, sold under the names EzriCare Artificial Tears Lubricant Eye Drops and Delsam Pharma Artificial Tears Lubricant Eye Drops, were recalled by their manufacturer, Global Pharma Healthcare, due to potential bacterial contamination. On Feb. 22, the recall expanded to include Delsam Pharma Artificial Eye Ointment as well.

Consumers should immediately stop using these eye drops and ointment if they have them.

The recall comes after the Centers for Disease Control and Prevention reported an outbreak of the bacteria Pseudomonas aeruginosa linked to the artificial tears. The strain of the bacteria, which had never been reported in the U.S. before, is particularly dangerous because it’s highly resistant to most antibiotics.

The CDC says that at least 58 people across 13 states have been infected in this outbreak. Five of them lost their vision and one person died. The bacteria were found in samples from infected people starting in May of 2022 and as recently as January 2023.

Investigators linked the infections to the artificial tears because infected people said they had recently used them. While they reported using a variety of brands, EzriCare artificial tears were used by a majority of the people. (Delsam Pharma artificial tears are included in the recall because they are also manufactured by Global Pharma Healthcare.)

Investigators then collected opened bottles of the product from infected and uninfected people in two different states and found bacterial contamination in some of the bottles. The CDC says it’s unclear whether the contamination happened after the bottles were opened or before, during the manufacturing process. That investigation is continuing.

Still, the FDA says it recommended the recall because the company didn’t adequately test its products for bacterial contamination and because it packaged the artificial tears in multiple-use bottles without adequate preservatives, in violation of the FDA’s Current Good Manufacturing Practice regulations. Such products are supposed to be sterile, according to the FDA.

Along with the recall, the FDA has placed an import alert on these products, so additional shipments are prevented from entering the U.S.

EzriCare didn’t return a February 3 request for comment. In a statement posted online, the company said its only role with the product was "to design an exterior label and market it to our customers.” A representative for Delsam told CR its product is being recalled “only because we had the same manufacturer.”

An FDA spokesperson told CR the recall was expanded to include the ointment product because of potential bacterial contamination. The agency didn’t offer any additional information but noted that the investigation is ongoing. The Delsam representative told CR only that it was following the recall as requested by the FDA.

Preservatives in Eye Drops

Preservative-free artificial tears can be an important treatment for people with chronic dry eyes, and they’re recommended for those who use artificial tears more than four times a day, according to the American Academy of Ophthalmology. That’s because the preservatives can actually further irritate the eyes.

But these preservative-free tears are usually sold in single-use packaging, not multiple-use bottles. Studies have found that multiple-use containers of preservative-free eye drops are prone to bacterial contamination.

“Multi-use preservative-free eye drop bottles have a higher risk of infectious contamination because, without antimicrobial preservatives, bacteria and fungus can proliferate potentially leading to sight-threatening infections,” says Christopher Starr, MD, clinical spokesperson for the American Academy of Ophthalmology. But because preservatives in high doses (more than four drops per day) can irritate the surface of the eye, he says, “we generally recommend preservative-free drops in single-use disposable containers for most people.”

What Consumers Should Know

If you’ve recently used EzriCare or Deslam Pharma preservative-free artificial tears, the CDC recommends staying alert for any possible symptoms of infection so that you can contact a healthcare provider immediately. These symptoms may include eye pain or discomfort, eye discharge, redness of the eye or eyelid, a feeling that there’s something in your eye, increased sensitivity to light, and blurry vision. And remember: If you have these eye drops or ointment, stop using them and throw them away.

The Details

The recall: All unexpired preservative-free artificial tears products under two brand names: EzriCare Artificial Tears Lubricant Eye Drops and Delsam Pharma Artificial Tears Lubricant Eye Drops. (Expired products should also not be used.) The boxes that the products come in are labeled with the following codes:

For Ezricare: NDC 79503-0101-15 and UPC 3 79503 10115 7
Delsam Pharma: NDC 72570-121-15 and UPC 72570-0121-15

Also, all products under the name: Delsam Pharma Artificial Eye Ointment (NDC 72570-122-35).

The risk: The products could be contaminated with a dangerous drug-resistant bacteria, Pseudomonas aeruginosa, which can cause severe disease, blindness, and death.

Incidents/injuries: An outbreak of the bacteria has sickened 55 people and killed one.

Where and when sold: The recall alert doesn’t list when the products were sold, though illnesses have occurred between May 2022 and January 2023. The FDA says the drops were sold online nationwide.

The remedy: If you have any of these products, stop using them immediately. If you notice any symptoms, contact a healthcare provider.

Contact information: If you have questions about the recall, contact the two distributors: Call Aru Pharma/EzriCare LLC at 518-738-7602 (Monday to Friday, 11 a.m. to 4 p.m. ET) or send an email to arupharmainc@yahoo.com. Or call Delsam Pharma LLC at 866-826-1309 (Monday to Friday, 11 a.m. to 4 p.m. ET) or send an email to delsampharma@yahoo.com.

Make a report: You can report adverse events from these products to the FDA.

Catherine Roberts

Catherine Roberts is a health and science journalist at Consumer Reports. She has been at CR since 2016, covering infectious diseases, bugs and bug sprays, consumer medical devices like hearing aids and blood pressure monitors, health privacy, and more. As a civilian, her passions include bike rides, horror films and fiction, and research rabbit holes. Follow her on Twitter @catharob.