The U.S. Food and Drug Administration has warned consumers to stop purchasing a host of over-the-counter eye drops due to a potential risk of infection that may lead to partial vision loss or blindness.
The FDA in late October recommended the manufacturer of 26 eye care products from CVS Health, Rite Aid and Target Up&Up, among others, to recall all lots after investigators found unsanitary conditions in the manufacturing facility and positive bacterial test results in "critical drug production areas" in the facility.
The FDA updated the list on Oct. 30 to include Equate Hydration PF Lubricant Eye Drop 10mL sold by Walmart in stores and online. Walmart has removed the product from their store shelves and website, according to the FDA.
The list was again updated on Nov. 3 after Cardinal Health initiated a voluntary recall for all lots of six Leader brand eye care products. The list originally included five Leader products and is now updated to include the sixth.
Additionally, Harvard Drug Group LLC initiated a voluntary recall for all lots of two Rugby Laboratories brand eye drops.
The recent recalls come after two other eye drop products were recalled in August, and another in February due to possible contamination, dozens infections and at least three deaths.
Infection risk:FDA tells consumers to stop using eye drops from major brands due to infection risk
All information is courtesy of the FDA.
Retailer/Label | Product | Product information | National Drug Code (NDC) |
CVS Health | Lubricant Eye Drops 15 ml (single pack) | Carboxymethylcellulose Sodium 0.5% | To be provided |
Lubricant Eye Drops 15 ml (twin pack) | Carboxymethylcellulose Sodium 0.5% | To be provided | |
Lubricant Gel Drops 15 ml (single pack) | Carboxymethylcellulose Sodium 1% | To be provided | |
Lubricant Gel Drops 15 ml (twin pack) | Carboxymethylcellulose Sodium 1% | To be provided | |
Multi-Action Relief Drops 15 ml | Polyvinyl Alcohol 0.5%, Povidone 0.6%, and Tetrahydrozoline Hydrochloride 0.05% | To be provided | |
Lubricating Gel drops 10 ml | Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3% | To be provided | |
Lubricant Eye Drops 10 ml (single pack) | Propylene Glycol 0.6% | To be provided | |
Lubricant Eye Drops 10 ml (twin pack) | Propylene Glycol 0.6% | To be provided | |
Mild Moderate Lubricating Eye Drops 15 ml (single pack) | Polyethylene Glycol 400 0.25% | To be provided | |
Leader (Cardinal Health) | Eye Irritation Relief 0.5 FL OZ (15 ml) | Polyvinyl Alcohol 0.5%, Povidone 0.6% and Tetrahydrozoline Hydrochloride 0.05% | 70000-0087-1 |
Dry Eye Relief 0.5 FL OZ (15 ml) | Carboxymethylcellulose Sodium 1% | 70000-0089-1 | |
Lubricant Eye Drops 0.5 FL OZ (15 ml) (single) | Carboxymethylcellulose Sodium 0.5% | 70000-0090-1 | |
Lubricant Eye Drops 0.5 FL OZ (15 ml) (twin pack) | Carboxymethylcellulose Sodium 0.5% | 70000-0090-2 (carton)70000-0090-1 (bottle) | |
Dry Eye Relief 0.33 FL OZ (10 ml) | Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3% | 70000-0088-1 | |
Lubricant Eye Drops 0.33 FL OZ (10 ml) | Polyethylene Glycol 0.6% | 70000-0587-1 | |
Rugby (Harvard Drug Group) | Lubricating Eye Drops 0.5 oz (15 ml) | Polyvinyl Alcohol 1.4% | 0536-1325-94 |
Lubricating Tears Eye Drops 0.5 oz (15 ml) | Dextran/Hypromellose 0.1%/0.3% | 0536-1282-94 | |
Rite Aid | Lubricant Eye Drops 15 ml (twin pack) | Carboxymethylcellulose Sodium 0.5% | To be provided |
Lubricant Eye Drops 10 ml (twin pack) | Propylene Glycol 0.6% | To be provided | |
Gentle Lubricant Gel Eye Drops 15 ml | Hypromellose 0.3%, Glycerin 0.2%, Dextran 70 0.1% | To be provided | |
Lubricant Gel Drops 15 ml | Carboxymethylcellulose Sodium 1% | To be provided | |
Lubricating Gel Drops 10 ml | Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3% | To be provided | |
Multi-Action Relief Drops 15 ml | Polyvinyl Alcohol 0.5%, Povidone 0.6% and Tetrahydrozoline Hydrochloride 0.05% | To be provided | |
Target | Up&Up Dry Eye Relief Lubricant Eye Drops 30 ml | Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3% | To be provided |
Up&Up Extreme Relief Dry Eye 15 ml (single pack) | Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3% | To be provided | |
Up&Up Extreme Relief Dry Eye 30 ml (twin pack) | Carboxymethylcellulose Sodium 0.5% | To be provided | |
Velocity Pharma LLC | Lubricant Eye Drop 10 ml (triple pack) | Propylene Glycol 0.6% | To be provided |
Walmart | Equate Hydration PF Lubricant Eye Drop 10 mL | Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3% | To be provided |
Product | Recall month | Recall reason |
Dr. Berne’s MSM Drops 5% Solution | August | Possible bacterial contamination |
LightEyez MSM Eye Drops – Eye Repair | August | Possible bacterial contamination |
Purely Soothing 15% MSM Drops | March | Non-sterility |
Clear Eyes Once Daily, Eye Allergy Itch Relief | February | Failed impurities specification |
Brimonidine Tartrate Ophthalmic Solutions, 0.15% | March | Potential lack of sterility |
In August, the FDA issued a notice warning consumers not to use Dr. Berne's MSM Drops 5% Solution and LightEyez MSM Eye Drops after the agency found bacterial contamination in some of them.
"Using contaminated eye drops could result in minor to serious vision-threatening infection which could possibly progress to a life-threatening infection," the FDA announced in the recall issued at the time.
According to the recall, both products contain methylsulfonylmethane (MSM), an unapproved drug illegally marketed in the U.S., the federal health regulator reported.
"There are no legally marketed ophthalmic drugs that contain MSM as an active ingredient," the FDA said.
In February, EzriCare Artificial Tears and Delsam Pharma Artificial Tears were recalled due to possible contamination after dozens of infections and at least four deaths.
The recall was later expanded to include Delsam Pharma’s Artificial Eye Ointment.
At least 81 infections were linked to EzriCare Artificial Tears, the CDC said in May.
The recall came after a CDC and FDA investigation on a multistate outbreak of VIM-GES-CRPA, which was new to the U.S.
'I want justice':Woman who lost her eye to infection sues recalled eyedrop maker EzriCare
People who have signs or symptoms of an eye infection after using these products should talk to their health care provider or seek medical care immediately, the FDA says.
The FDA also recommends consumers properly discard these products.
There have been no reports of eye infection associated with these products as of Friday, but the FDA encourages health care professionals and patients to report adverse events or quality problems with any medicine to the agency's MedWatch Adverse Event Reporting Program.
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