In general, over-the-counter artificial tears and lubricating eye drops are safe when used as directed. They are designed to mimic the natural tears and provide relief for dry eyes. However, it is essential to follow the instructions on the product packaging and consult with an eye care professional if you have any concerns or specific conditions.
On February 2, 2023, the FDA recalled EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears due to potential bacterial contamination. Per the FDA press release, they "FDA recommended this recall due to the company’s current good manufacturing practice (CGMP) violations, including lack of appropriate microbial testing, formulation issues (the company manufactures and distributes ophthalmic drugs in multi-use bottles, without an adequate preservative), and lack of proper controls concerning tamper-evident packaging." The release goes on to say this product was linked to a "multistate outbreak involving a rare, extensively drug-resistant strain of Pseudomonas aeruginosa bacteria" that led to hospitalization, [multiple deaths from bloodstream infection], and permanent vision loss from eye infections."
One big red flag just from reading the EzriCare Artificial Tear box comes from statement below Artificial Tears that says "Compare to the active ingredients in Refresh Plus Eye Drops". Allergan's Refresh Plus eye drops come in preservative free dropperettes. Although it is a lot of packaging, each dropperette is sealed and sterile. So it is a critical flaw of the EzriCare Artificial Tears that a large 15mL bottle would contain no preservatives. A multi-use bottle must contain either preservatives (most commonly benzalkonium chloride) or the bottle must be specially designed to ensure sterility (systane complete PF and ivizia are examples of this special bottle design).
On October 27, 2023, the FDA additionally recalled "26 over-the-counter eye drop products due to the potential risk of eye infections that could result in partial vision loss or blindness." The products included the recall include store branded products below:
CVS Health
Leader (Cardinal Health)
Rugby (Cardinal Health)
Rite Aid
Target Up & Up
Velocity Pharma
Walmart Equate Hydration PF
"These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses."
"FDA recommended the manufacturer of these products recall all lots on October 25, 2023, after agency investigators found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility. FDA also recommends consumers properly discard these products."
Keep in mind that product recalls can happen for various reasons, including concerns about product quality, safety, or labeling issues. It is very important to stay informed about such recalls, especially when it comes to products that you use for your health.
Given the severity and frequency of the recalls, it is natural to question the safety of all of our eye drops. However, our branded eye drops like Refresh, Systane, Blink, Soothe, TheraTears are more safer and more important than ever. We have a list of our favorite eye drops available here. Evidence that suggests that appropriate, regular and continuous use of lubricating eye drops and artificial tears reduces long-term ocular surface inflammation preserving ocular function. Balancing safety while combatting chronic inflammation is one of the most delicate balancing acts that becomes harder as we get older.
Here are some general guidelines for using eye drops safely:
Follow Instructions: Always follow the recommended dosage and frequency as indicated on the eye drop packaging or as directed by your eye care professional.
Avoid Contamination: Wash your hands before using eye drops to prevent contamination. Be careful not to touch the tip of the dropper, and do not let it come into contact with any surface.
Check for Allergies: If you have known allergies or sensitivities, check the ingredients of the eye drops to avoid any potential allergic reactions.
Use Preservative-Free Drops, if Needed: Some people may be sensitive to the preservatives in eye drops. If you need to use artificial tears frequently, preservative-free options are available.
Wait Between Drops: If you need to use more than one type of eye drop or medication, wait at least 5-10 minutes between applications to allow the first drop to be absorbed.
Discard Expired Products: Check the expiration date on the eye drop packaging, and do not use drops that have expired.
If you experience persistent or worsening symptoms, it's crucial to consult with an eye care professional. They can provide a proper diagnosis, recommend appropriate treatments, and ensure that your symptoms are not indicative of a more serious underlying condition.