Several eye care products sold nationwide have been recalled due to safety risks. The U.S. Food and Drug Administration (FDA) found issues during an audit, prompting BRS Analytical Service, LLC to issue a voluntary recall. Consumers are advised to stop using these products immediately.
What Happened?
The recall follows the FDA’s discovery of manufacturing problems. These issues stem from failures to follow current Good Manufacturing Practices (cGMP). As a result, the quality of the products may be compromised, posing a potential risk to users.
BRS Analytical Service is recalling five eye care products made and sold between May 26, 2023, and April 21, 2025.
Affected Products
The affected products include:
- Artificial Tears Ophthalmic Solution (NDC# 50268-043-15)
- Carboxymethylcellulose Sodium Ophthalmic Gel 1% (NDC# 50268-066-15)
- Carboxymethylcellulose Sodium Ophthalmic Solution (NDC# 50268-068-15)
- Lubricant Eye Drops Solution (NDC# 50268-126-15)
- Polyvinyl Alcohol Ophthalmic Solution (NDC# 50268-678-15)
These products are typically used to relieve dry eyes and irritation. If produced incorrectly, they could cause eye infections, vision problems, or even severe damage to the eyes.
What Should Consumers Do?
Consumers using these eye drops should stop immediately. Even if there are no symptoms, it’s safer to discontinue use.
This applies even if the product has already been discarded.
FDA’s Response
The FDA regularly inspects manufacturing plants to ensure compliance with safety regulations. In this case, the agency found that BRS Analytical Service had not met basic quality standards.
Under current guidelines, manufacturers must ensure their products are made in clean facilities with thorough quality checks at every stage. Any lapse in this process can result in unsafe products reaching consumers.
Are There Any Reports of Harm?
No injuries or health issues have been reported from these products so far. However, experts caution that eye drops produced under poor conditions can be risky. Contaminated drops can lead to eye infections or even cause permanent vision loss.
What Is Carboxymethylcellulose?
Carboxymethylcellulose sodium is a common ingredient in the recalled products. It works as a thickening agent, helping the eye drops stay on the eye longer. This ingredient is used to treat dry or irritated eyes.
However, the safety of these drops relies on sterile production. Contamination during the manufacturing process could cause serious health risks.
Previous Recalls in the Industry
This isn’t the first time eye care products have been recalled. In 2023, a similar situation occurred when another company had to pull artificial tears from the market due to bacterial contamination. That incident led to hospitalizations and, tragically, a few deaths.
This new recall highlights the ongoing need for strong oversight in the pharmaceutical industry.
Safe Alternatives
Consumers can still find safe alternatives for dry or irritated eyes. Experts recommend choosing products from trusted brands and ensuring they have FDA approval. If unsure, it’s a good idea to consult with a doctor or pharmacist before using any over-the-counter eye drops.
Also, remember to store eye care products in a cool, dry place and avoid using them past their expiration date.
What to Watch for
If you’ve used any of the recalled products and experience symptoms like:
- Redness
- Eye pain
- Blurred vision
- Unusual discharge
Seek medical attention immediately.
Taking care of your eye health is crucial. If you’re using an affected product, it’s better to stop using it than risk further harm. Stay informed by visiting the FDA’s official recall page for updates.
