Why Does the FDA Keep Recalling Eye Drops?
You may be tired of hearing about eye drop recalls, but the FDA has released a new list of eye drops that you should stop using. This time it includes lubricant eye drops from Target, CVS and Rite Aid brands. When we first wrote about these brands in October, the FDA recommended a recall based on tests that revealed potential bacterial contamination. As of November 15, 2023, the manufacturer has officially recalled these drops .
Which eye drops are affected?
The full list is here , and includes eye drops made by the same manufacturer and sold under different brand names. If you have these brands of drops, check the exact name and package size against the FDA listing. These include:
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CVS Health (Lubricant Eye Drops, Lubricating Gel Eye Drops, Multi-Action Drops, and Mild to Moderate Lubricant Eye Drops)
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Rugby/Cardinal Health (tear lubricating eye drops, polyvinyl alcohol lubricating eye drops 1.4%)
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Leader/Cardinal Health (dry eye, lubricating eye drops, eye irritation)
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Rite Aid (Lubricating Eye Drops, Lubricating Gel Gentle Eye Drops, Lubricating Gel Drops, Multi-Action Drops)
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Target Up & Up (Dry Eye Relief Eye Drops, Extreme Dry Eye Relief)
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Velocity Pharma LLC (lubricating eye drops)
The recall affects products with expiration dates between November 2023 and September 2025. In addition to the FDA list above, you can also check this recall list with the manufacturer .
What’s wrong with these eye drops?
Unlike a recall earlier this year , these eye drops have not (yet) been linked to specific illnesses or deaths. The FDA has found a potential risk of eye infections that can lead to vision loss:
The FDA recommended that the manufacturer of these products recall all lots on October 25, 2023, after agency investigators found unsanitary conditions at the manufacturing facility and positive bacterial test results from environmental sampling in critical drug manufacturing areas of the facility. The FDA also advises consumers to properly avoid these products.
If you experience symptoms of an eye infection after using these drops, the FDA recommends that you talk to your doctor or seek medical attention. Symptoms of infection may include pain, redness, itching, swelling, or new changes in vision.
Is this related to other eye drop warnings and reviews?
This warning is not directly related to previous ones this year, but it is reasonable to assume that after the outbreak of the deadly eye infection in early 2023, increased attention will be paid to eye drop manufacturers. Here’s a summary of the main recalls and warnings about the eye drops. this year:
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Earlier this year, the CDC and FDA worked together to track the source of an outbreak of drug-resistant Pseudomonas aeruginosa infection. The bacteria from these infections were resistant to several different antibiotics, and 81 cases of these infections were reported in 18 states. Four people died, four people had to have their eyeballs removed, and 14 lost their sight. This outbreak involved EzriCare products and Delsam Pharma artificial tears. The FDA warning about these products, originally issued in February 2023 and updated several times, is here .
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In March 2023 , Apotex recalled brimonidine tartrate eye drops because the caps on some bottles were broken and could easily become contaminated.
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Also in March 2023 , Pharmamedica USA announced a recall of its MSM (methylsulfonylmethane) drops due to potential contamination.
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In August 2023, the FDA issued a warning about Dr. Berne’s and LightEyes MSM due to contamination by bacterial and fungal species.
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And in September, the FDA issued warning letters to the manufacturers of eight brands of eye drops , including various products from Boiron, Similisan, CVS Health, Walgreens Boots Alliance and others. Some products had “quality issues” during production, which meant they could not be relied upon to be sterile; some used silver, which can cause the eyes and skin to turn gray over time, a condition called argyria ; and some were homeopathic, a category of “medicine” based on a long-discredited theory . (The FDA allows homeopathic “medicines” on the market as long as they do not pose a serious risk to users; they were considered risky enough to be withdrawn.) Some brands have had a variety of problems, so double-check your specific products. against those named in the warning letters.