FDA Recalls Some Artificial Tear Eye Drops

December 29, 2025 | Personal Injury

FDA Recalls Some Artificial Tear Eye Drops

Artificial tear eye drops are commonly used to relieve dry eyes, irritation, and discomfort. Many people assume these products are completely safe because they are sold over the counter. 

However, recent FDA recalls have raised serious concerns about contamination, infections, and long-term eye damage. If you have used artificial tear eye drops, it is important to understand what these recalls involve and what steps you should take to protect your health.

Why the FDA Is Recalling Artificial Tear Eye Drops

The FDA has recalled certain artificial tear products after discovering unsafe manufacturing conditions and contamination risks. In several cases, products were found to contain bacteria that should never be present in eye medications. Because eye drops go directly into the eye, even small amounts of contamination can cause severe eye injury.

The most common reasons for these recalls include the following issues:

  • Bacterial contamination, including drug-resistant bacteria
  • Unsanitary manufacturing conditions
  • Failure to meet sterility standards
  • Improper packaging that allowed contamination
  • Inadequate quality control testing

When these problems occur, the FDA may issue a recall to remove the products from store shelves and warn consumers to stop using them immediately.

Which Artificial Tear Products Have Been Affected

The FDA has issued recalls involving several brands of artificial tear eye drops sold nationwide. 

Some of these products were marketed as preservative-free or intended for sensitive eyes, which made them especially appealing to frequent users.

While recall lists change as investigations continue, affected products have included:

  • Multi-dose artificial tear bottles
  • Preservative-free artificial tears
  • Lubricating eye drops for dry eye relief
  • Gel-based artificial tear products

Consumers should always check the FDA’s recall announcements to see whether a specific brand, lot number, or expiration date is included.

Health Risks Linked to Contaminated Eye Drops

Using contaminated artificial tear eye drops can lead to serious medical complications. In some reported cases, patients suffered permanent vision loss after developing severe eye infections.

Potential injuries associated with recalled eye drops include:

  • Eye infections such as keratitis
  • Corneal ulcers or scarring
  • Severe eye pain or swelling
  • Blurred vision or vision loss
  • Bloodstream infections in extreme cases

Because eye infections can worsen quickly, prompt medical attention is critical if symptoms appear.

Symptoms to Watch For After Using Recalled Eye Drops

If you have used artificial tear eye drops that were later recalled, pay close attention to any changes in your eyes or vision. Symptoms may appear within days or weeks after use.

Common warning signs include:

  • Redness or irritation that does not improve
  • Eye pain or pressure
  • Sensitivity to light
  • Discharge from the eye
  • Sudden changes in vision

If you experience any of these symptoms, stop using the product and seek medical care right away.

What to Do If You Used a Recalled Eye Drop Product

If you discover that you used a recalled artificial tear product, taking the right steps can help protect your health and your legal rights.

You should take the following actions as soon as possible:

  • Stop using the product immediately
  • Keep the bottle, packaging, and receipt if available
  • Write down when you used the eye drops and any symptoms
  • Seek medical treatment for any eye problems
  • Follow FDA instructions regarding disposal or returns

Medical records and product information can be important if complications develop later.

In some cases, consumers who were harmed by recalled eye drops may have the right to pursue a legal claim. Manufacturers have a responsibility to ensure that eye medications are safe, sterile, and properly tested before being sold.

Legal claims may be possible if:

  • The product was contaminated or defectively manufactured
  • The manufacturer failed to follow safety standards
  • You suffered an eye injury or infection
  • Medical treatment was required
  • Vision loss or permanent damage occurred

Product liability claims can help injured consumers recover compensation for medical expenses, lost income, and long-term vision problems.

Contact Marzzacco Niven & Associates for a Free Consultation 

FDA recalls of artificial tear eye drops are a serious reminder that even over-the-counter products can pose significant health risks when safety standards are not followed. If you have used a recalled eye drop product, staying informed, seeking prompt medical care, and preserving any evidence can make a critical difference in protecting your eyesight and your legal options. 

If you believe you were injured by a recalled artificial tear product, contacting an experienced attorney can help you understand your rights and pursue the compensation you deserve. Contact Marzzacco Niven & Associates today for a free consultation. 

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