An imported artificial eye lubricant recalled last month has now been linked to three deaths and a dozen serious injuries, U.S. health officials report.

EzriCare Artificial Tears and Delsam Artificial Tears, over-the-counter eye drop medications produced in India, were recalled in February due to sterility concerns and possible bacterial contamination. 

A Centers for Disease Control and Prevention report now says the drops are linked to nearly 70 sickened patients in 16 states. 

In addition to the fatalities, eight people have reported permanent vision loss and four others lost an eye. Officials say a rare strain of drug-resistant bacteria, Pseudomonas aeruginosa, is to blame. The bacterium had never been found in the U.S. prior to the outbreak. 

Consumers should stop using the products immediately and report any adverse effects to a doctor. Many people who used contaminated EzriCare Artificial Tears or Delsam Artificial Tears and were injured as a direct result have begun filing lawsuits

More Than Half of Affected Patients Linked to Care Facilities

The CDC had previously announced on March 14 that 68 patients in 16 states were involved in the outbreak. More than half of the patients were linked to four health care facility clusters, the CDC reported. The locations of the facilities have not been released, but officials report patients are from California, Colorado, Connecticut, Florida, Illinois, North Carolina, New Jersey, New Mexico, New York, Nevada, Pennsylvania, South Dakota, Texas, Utah, Washington and Wisconsin. 

Most sickened patients reported using artificial tears before becoming infected. EzriCare Artificial Tears was the most reported brand, the CDC said. EzriCare was the only brand reported across the four health care facilities. Labs found the same strain of bacteria in opened EzriCare bottles from various lots. Testing on unopened bottles of EzriCare eye drops is ongoing. It’s unclear whether contamination occurred during production. 

Global Pharma Healthcare, the company that manufactures EzriCare Artificial Tears and Delsam Pharma’s Eye Ointment, recalled both products in February. It released a statement that month announcing the recall but has not commented on the latest reported injuries.

In a statement to, eye drop distributor Aru Pharma said the company “has taken all available steps to protect the end users of these products despite having no role in their formulation or sale to consumers.”

“From the outset, Aru Pharma has cooperated fully with the Food and Drug Administration in its effort to remove EzriCare Artificial Tears from the market due to claims of serious adverse health effects suffered by users of these eye drops” according to its attorney, Neil Flynn.

Consumers Urged to Discontinue Use

Consumers who have experienced any ill effects from using EzriCare or Delsam Pharma eye drops should report the issue to the FDA.  

Eye infection symptoms may include:

  • Blurry vision
  • Eye pain or discomfort
  • Feeling of something in your eye 
  • Increased sensitivity to light
  • Redness of the eye or eyelid
  • Yellow, green, or clear discharge from the eye

Consumers who used the brands and experienced any eye drops side effects should seek medical care immediately.