FDA Announces Recall of 27 More Eye Drop Products, Due to Risk of Eye Infection — the Full List
Check your eye drops — the FDA is recalling a number of eye drop products due to the risk of serious infection.
Nov. 16 2023, Updated 10:47 a.m. ET
The Gist:
- In early 2023, several brands of eye drops were recalled, because of a bacterial contamination.
- Then in October 2023, the FDA advised the makers of more eye products to issue recalls, claiming that the products could cause infections that may lead to blindness.
- Then, in November 2023, the FDA announced a recall of 27 eye drop products.
- If you have any of these eye drops at home, you should stop using them immediately.
Earlier in 2023, several eye drop companies were forced to recall products due to bacterial contamination from a drug-resistant strain of Pseudomonas aeruginosa. And unfortunately, various affected people suffered from various infections — and some were even fatal.
Then, in October 2023, the FDA called upon the makers of 26 eye drop products, asking them to issue recalls; a month later, the FDA announced a recall of 27 eye drop products, some of which overlap from the previous month's warning.
Keep reading for what we know about all this, and what to do if you have any of the affected products in your medicine cabinet.
The FDA published a recall of 27 eye drop products in November 2023.
On Nov. 15, 2023, India-based company Kilitch Healthcare India Limited issued a voluntary recall of various eye drops. The FDA reported that its investigators discovered "insanitary conditions" that posed potential safety hazards.
Lots of the following products with expiration dates between November 2023 and September 2025 are being recalled:
- Rugby: Lubricating Tears Eye Drops 15 ml, Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15 ml
- Target: High Performance Lubricant Eye Drops 15 ml (Single Pack), High Performance Lubricant Eye Drops 15 ml (Twin Pack), Dry Eye Relief 15 ml (Twin Pack)
- Rite Aid: Multi-action Relief Drops 15ml, Lubricating Gel Drops 10ml, Lubricant Eye Drops 10ml (Twin Pack), Lubricant Gel Drops 15 ml, Lubricant Eye Drops 15ml (Twin Pack)
- Leader: Eye Irritation Relief 15 ml, Dry Eye Relief 10 ml, Dry Eye Relief 15 ml, Lubricant Eye Drops 15 ml (Single Pack), Lubricant Eye Drops 15 ml (Twin Pack), Lubricant Eye Drops 10 ml
- Velocity: Lubricant Eye Drop 10ml (Triple Pack)
- CVS: 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, Mild Moderate Lubricating Eye Drops 15 ml, Lubricant Gel Drops 10 ml, Lubricant Eye Drops 10 ml (Single Pack), Lubricant Eye Drops 10 ml (Twin Pack)
- Walmart: Equate Hydration Pf Lubricant Eye Drops 10 ml.
The FDA is advising customers who have been using any of the recalled eye drops to stop, and to return the product wherever you purchased it.
You can contact regulatory@velocitypharma.com or regulatory@kilitchhealthcare.com with any questions, and contact a doctor if you have any health concerns regarding your use of the product.
The FDA issued a warning against 26 eye drops in October 2023.
On Friday, Oct. 27, 2023, the FDA published an article urging consumers to avoid 26 specific eye drop products made by six companies, stating that they pose "a potential risk of eye infections that could result in partial vision loss or blindness."
Two days prior, the FDA advised the six brands to issue recalls.
As per the FDA, the 26 products are as follows:
- 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).
- 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.
- Rugby (Cardinal Health): Lubricating Tears Eye Drops 15 ml, Polyvinyl Alcohol 1.4% Lubricating Eye Drops 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: 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).
Obviously, this is a serious issue — so if you use eye drops, make sure to check the list to see if your products of choice are listed. If they are, the FDA suggests disposing of them.
As of publication, the FDA is not reporting any consumer infections due to these products; however, if you are concerned, report your experience to the FDA’s MedWatch Adverse Event Reporting program, and make sure to consult with your physician.
In March 2023, many other eye drops were recalled.
Earlier this year, the FDA was pointing fingers at Global Pharma, an India-based healthcare company that reportedly sold contaminated eye drops to the U.S. As of March 21, 2023 per the CDC, 68 patients in 16 states (California, Colorado, Connecticut, Florida, Illinois, North Carolina, New Jersey, New Mexico, New York, Nevada, Pennsylvania, South Dakota, Texas, Utah, Washington, and Wisconsin) had been infected by P. aeruginosa.
Global Pharma's recalled eye drop brands included EzriCare and Delsam Pharma — specifically EzriCare's Artificial Tears Lubricant Eye Drops and both Delsam Pharma's Artificial Tears and its Artificial Eye Ointment. Apotex Corp. and Pharmedica USA also recalled eye drop products, per NPR; however there weren't any reports that they'd caused infections.
Symptoms of eye infections from P. aeruginosa include: eye discharge or discomfort, redness of the eye, blurry vision, or light sensitivity.
In very extreme cases of these types of infections, the infection can spread to other parts of the body, such as the bloodstream. According to NPR, at least eight people became blind and four had to get their eyeballs surgically removed, as of March 22, 2023. Three people also reportedly succumbed to their infections and passed away.
The FDA blamed Global Pharma for using inadequate packaging and for not using proper preservatives to stave off bacteria.
"The patients' eyes were painfully inflamed. They could sense light but could see almost nothing else. A doctor called one case the worst eye infection he'd ever seen," Mike Stobbe of AP News wrote in a February piece, before even more brands ended up recalling their products.
"It was the beginning of a national outbreak caused by an extremely worrisome bacteria — one that some say heralds an era in which antibiotics no longer work and seemingly routine infections get horribly out of hand," the article added.
What is Pseudomonas aeruginosa?
Pseudomonas aeruginosa is a strain of bacteria that can cause severe infections — particularly among hosts who are already immunocompromised, according to the CDC. That said, it comes as no surprise that the vast majority of reported infections in 2023 took place in healthcare facilities.
Beyond being detected in certain types of medications and sometimes on medical equipment, the bacteria is also sometimes found in nature. However that is much less common, particularly in the U.S.
According to the National Library of Medicine, Pseudomonas aeruginosa is highly resistant to antibiotics, which makes it extremely challenging to treat once its infected someone.
So make sure to double check that your eye drops aren't affected by any warnings or recalls.
This article, originally published on March 23, 2023, has been updated to include the October 2023 eye drop warning and November 2023 eye drop recall.
