FDA Issues Additional Warnings for Name Brand Eye Drops, Prompts Recalls

FDA Issues Additional Warnings for Name Brand Eye Drops, Prompts Recalls

Over the course of the past several months, the Food and Drug Administration (FDA) has increased factory and facility inspections after a lull connected to the pandemic. In the process, the regulatory agency has discovered that the production sites of prominent eye drop producers exhibited unsanitary conditions which pose severe health risks to users. 

Although the FDA has limited authority to issue recalls, it has increased pressure on manufacturers and retailers like CVS Health and Rite Aid to remove contaminated products from store shelves. In response, producers and suppliers have initiated voluntary recalls for over-the-counter eye drops. 

However, the unclean and unsafe conditions in which the eye drops were produced have already contributed to partial or total vision loss in consumers across the country. This latest news of eye drop contamination echoes earlier controversy in 2023 revolving around Ezricare eye drops and infections they similarly caused due to problems with contamination. Those injured by this product have filed Ezricare eye drop lawsuits to seek compensation for damages ranging from medical bills to pain and suffering.

The FDA was scheduled to perform over 1,000 in-person site inspections for fiscal year 2020. However, the onset of the pandemic and extensive safety concerns effectively postponed or canceled the critical investigations to scrutinize manufacturer adherence to federal regulations. 

In the following years, the FDA began to receive reports that a series of popular eye drops were linked to potentially life-threatening fungal and bacterial infections. By February 2023, the agency had received at least one authoritative report of a fatality connected with the use of a contaminated eye drop product. 

After conducting extensive site inspections, the FDA discovered that the manufacturers of popular eye drops had failed to clean equipment thoroughly, which directly led to the production and distribution of contaminated products. 

Eye Drop Producers and Retailers Initiate Recalls

Technically, the FDA does not have the power or authority to issue mandatory recalls for eye drops. Although Congress has considered various legislative initiatives to expand the scope of the FDA’s recall power for OTC and prescription medications, none has been ratified. 

Consequently, the agency must rely upon indirect pressures to compel manufacturers and retailers to remove definitively dangerous products from their shelves. In an effort to mitigate fatalities and prevent serious eye infections, the FDA released a series of eye drop warnings that listed the name brands and retailers of popular eye drop products, which include: 

  • CVS Health
  • Rite Aid
  • Leader
  • Rugby

In response, companies across the country initiated eye drop voluntary recalls to avoid the specter of litigation from the FDA. Within the past month, Walmart, Harvard Drug Group LLC, Cardinal Health, Inc., and Kilitch Healthcare India Limited have undertaken negotiations with the FDA to devise recall lists that are amenable to federal regulators and potentially liable corporations. 

Symptoms Linked to Bacterial and Fungal Eye Drop Contamination

If you used any of the FDA-listed eye drops and subsequently developed a life-altering or life-threatening medical condition, the most important thing to do is seek immediate medical attention. The various bacteria and fungi that the FDA detected in batches of eye drop products have the potential to cause both short-term and long-term vision loss. 

Although the symptoms of infections caused by eye drop products vary, common warning signs include: 

  • Redness
  • Irritation
  • Pain 
  • Discharge
  • Vision loss
  • Blindness

EzriCare Eye Drops Contained Traces of Drug-Resistant Bacteria

At the same time the FDA was conducting site inspections, it was working in conjunction with the Centers for Disease Control (CDC) to determine the health risks associated with EzriCare and Delsam Pharma Artificial Tear products. The development occurred after the FDA and CDC concluded that a multistate outbreak of Pseudomonas aeruginosa was directly linked to Global Pharma’s unhygienic manufacture. 

In order to determine the extent of the first-of-its-kind outbreak, the CDC collaborated with the health departments in 18 states, concluding that the following products contributed to the infections:

  • EzriCare Artificial Tears
  • Delsam Pharma Artificial Tears
  • Delsam Pharma Artificial Ointment

The manufacturer, Global Pharma, now faces the risk of Ezricare eye drop product liability lawsuits from those who sustained severe injuries on account of its negligence and failure to warn the public. 

Common Damages in Ezricare Contaminated Eye Drop Lawsuits

Developing a severe eye infection can dramatically impact an individual’s life. Aside from requiring extensive appointments with an ophthalmologist and a potentially robust regimen of antibiotics, it can also inhibit their ability to work or perform daily tasks. 

Now that the FDA and CDC have established the extent to which prominent manufacturers of popular eye drops failed to clean their equipment, users across the country are determining whether or not to seek compensation for their injuries. 

In an eye drop product liability lawsuit, you have the opportunity to seek financial assistance from irresponsible or reckless manufacturers in the form of economic and non-economic damages which address:

  • Medical expenses – past, present, and future
  • Lost wages or income
  • Pain and suffering
  • Mental anguish
  • Decreased quality of life 
  • Wrongful death

In order to determine the precise amount in damages to which you may be entitled, it is imperative that you speak with a qualified product liability lawyer

Contact an Experienced Product Liability Lawyer for Your Ezricare Eye Drop Lawsuit Today

Although corporate responses to FDA and CDC pressure have been largely cooperative, the manufacturers of eye drop products nevertheless endangered the public and cost users time, money, and even their sight. That is why our talented and accomplished legal team is on standby to provide the victims of contaminated eye drops with the assistance and advice they need as they recuperate from a traumatic health emergency. 

In a free consultation, we can explain the liability of eye drop manufacturers and distributors, the eligibility of your claim, and the compensation to which you may be entitled. Ultimately, our goal is to ensure that you have all the information you need to make a fully informed decision about how best to protect your rights while preserving your health. 

With over 120 combined years of personal injury law experience, we fuse the individualized treatment of a small firm with the resources and heft of a nationwide practice. For more information, consider contacting us today.


Matthew Dolman

Personal Injury Lawyer

This article was written and reviewed by Matthew Dolman. Matt has been a practicing civil trial, personal injury, products liability, and mass tort lawyer since 2004. He has represented over 11,000 injury victims and has served as lead counsel in over 1000 lawsuits. Matt is a lifetime member of the Million Dollar Advocates Forum and Multi-Million Dollar Advocates Forum for resolving individual cases in excess of $1 million and $2 million, respectively. He has also been selected by his colleagues as a Florida Superlawyer and as a member of Florida’s Legal Elite on multiple occasions. Further, Matt has been quoted in the media numerous times and is a sought-after speaker on a variety of legal issues and topics.

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