In late October 2023, the U.S. Food and Drug Administration (FDA) issued warnings against purchasing and using various over-the-counter eye drop products due to potential risk of eye infections that could lead to vision loss or blindness.
Cardinal Health Inc. voluntarily recalled all lots of six Leader brand ophthalmic products, adding a sixth product to the previously listed five.
Additionally, Harvard Drug Group LLC recalled all lots of two Rugby Laboratories brand eye drops.
The FDA updated its list to include the national drug codes of these products.
On October 30, the FDA added Walmart’s Equate Hydration PF Lubricant Eye Drop 10 mL to the list, leading Walmart to remove the product from store shelves and online.
The initial warning on October 27 advised against using 26 over-the-counter eye drop products marketed under brands like CVS Health, Leader, Rugby, Rite Aid, Target Up & Up, and Velocity Pharma.
These products, meant to be sterile, pose a heightened risk as they bypass the body’s natural defenses.
The FDA’s recommendation for a recall came after finding insanitary conditions and positive bacterial tests in critical drug production areas in the manufacturing facility.
CVS, Rite Aid, and Target have removed the affected products from sale, but some Leader, Rugby, and Velocity products might still be available and should not be purchased.
As of the report, the FDA hadn’t received any adverse event reports related to these products but encourages reporting of any adverse events to their MedWatch program.
If you or a loved one used any of the recalled eye drops or artificial tears and subsequently experience eye infection symptoms, vision loss, or other related health issues, you may be eligible to file a claim.
Contact TorHoerman Law for a free consultation.
Use the chatbot on this page to find out if you qualify for a Contaminated Eye Drop Lawsuit claim instantly.
Investigation Finds Unsanitary Conditions at Manufacturing Facilities in India
Tainted over-the-counter eyedrops, recalled by the FDA and pulled from major retailers like CVS, Rite Aid, Walmart, and Target, were reportedly made under unsanitary conditions in a factory in Navi Mumbai, India.
A Bloomberg investigation revealed Kilitch Healthcare India Ltd. as the manufacturer, where workers were found barefoot or without protective gear in sterile areas, and safety test results were allegedly falsified.
This situation reveals a gap in the FDA’s oversight of over-the-counter medicines, allowing inexperienced Indian entrepreneurs to export these products to the U.S.
Despite India’s significant role in pharmaceutical manufacturing, the FDA has limited power to enforce recalls.
However, they banned the Kilitch factory from exporting more eyedrops to the U.S. after an inspection.
The FDA has issued warnings about 78 over-the-counter eyedrops this year, but only 13 have been recalled.
The Dry Eye Foundation raised concerns about the rising number of risky eye drops in the U.S. market.
The FDA also warned about severe infections potentially leading to life-threatening conditions related to other eyedrop products, including Dr. Berne’s Organic Castor Oil Eye Drops and Dr. Berne’s MSM Mist 15% Solution.
Drug Resistant Bacteria Found in Other Recalled Eye Drops
Another case from earlier this year, which our lawyers are also investigating, again involved contaminated artificial tears and eye drops manufactured in India under unsanitary conditions.
EzriCare and Delsam Pharma’s Artificial Tears Lubricant Eye Drops were recalled due to bacterial infections, severe injuries, and four deaths in the United States.
The companies are currently facing lawsuits from individuals who have suffered as a result of using these contaminated artificial tears.
Our attorneys are currently accepting new clients for the EzriCare Artificial Tears Lawsuit.
Some patients who used EzriCare or Delsam Pharma’s artificial tears suffered severe injuries and complications, including the removal of eyeballs and long-lasting migraines.
While the EzriCare and Delsam Pharma lawsuit has been in the focus of regulators and attorneys, other eye drops have also been recalled this year.
In August 2023, the FDA warned consumers not to purchase and to immediately stop using Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops – Eye Repair due to bacterial contamination, fungal contamination, or both.
