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Eye drop recall list: See the dozens of eye care products recalled in 2023

2024-12-24 11:24:31 source: Category:Finance

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

Eye drop recall list

All information is courtesy of the FDA.

Retailer/LabelProductProduct informationNational Drug Code (NDC)
CVS HealthLubricant 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 mlPolyvinyl Alcohol 0.5%, Povidone 0.6%, and Tetrahydrozoline Hydrochloride 0.05%To be provided
Lubricating Gel drops 10 mlPolyethylene 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 AidLubricant 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 mlHypromellose 0.3%, Glycerin 0.2%, Dextran 70 0.1%To be provided
Lubricant Gel Drops 15 mlCarboxymethylcellulose Sodium 1%To be provided
Lubricating Gel Drops 10 mlPolyethylene Glycol 400 0.4% and Propylene Glycol 0.3%To be provided
Multi-Action Relief Drops 15 mlPolyvinyl Alcohol 0.5%, Povidone 0.6% and Tetrahydrozoline Hydrochloride 0.05%To be provided
TargetUp&Up Dry Eye Relief Lubricant Eye Drops 30 mlPolyethylene 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 LLCLubricant Eye Drop 10 ml (triple pack)Propylene Glycol 0.6%To be provided
WalmartEquate Hydration PF Lubricant Eye Drop 10 mLPolyethylene Glycol 400 0.4% and Propylene Glycol 0.3%To be provided

Prior eye drop recalls include EzriCare, Dr. Berne’s and LightEyez

ProductRecall monthRecall reason
Dr. Berne’s MSM Drops 5% SolutionAugustPossible bacterial contamination
LightEyez MSM Eye Drops – Eye RepairAugustPossible bacterial contamination
Purely Soothing 15% MSM DropsMarchNon-sterility
Clear Eyes Once Daily, Eye Allergy Itch ReliefFebruaryFailed impurities specification
Brimonidine Tartrate Ophthalmic Solutions, 0.15%MarchPotential lack of sterility

Dr. Berne's and LightEyez:

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.

EzriCare and Delsam Artificial Tears recalled

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

What should you do if you have used these products?

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.