Nationwide Eye Care Product Recall: What You Need to Know

Over 1.8 million cartons of eye care products have been recalled across the U.S. due to safety concerns. Customers are being urged to stop using these items immediately and return them for a full refund. The recall, announced by healthcare distributor AvKARE, impacts five types of eye drops and gels sold nationwide.

Why Were These Products Recalled?

The recall follows a U.S. Food and Drug Administration (FDA) inspection of BRS Analytical Service, LLC, the company responsible for manufacturing the products. The FDA found violations of Current Good Manufacturing Practice (CGMP) rules, which ensure drugs are made safely and consistently. While no specific health risks have been confirmed, the FDA warned that these violations could lead to “unacceptable quality” in the products, including potential sterility issues.

Sterility is critical for eye care solutions because contaminated products can cause infections, vision problems, or even blindness. The FDA classified this as a Class II recall, meaning using these products might result in serious health consequences or death.

Which Products Are Affected?

The recalled items include:

• Artificial Tears Ophthalmic Solution
• Carboxymethylcellulose Sodium Ophthalmic Gel 1%
• Carboxymethylcellulose Sodium Ophthalmic Solution
• Lubricant Eye Drops Solution

Polyvinyl Alcohol Ophthalmic Solution

These products were distributed between May 2023 and April 2025. Customers can check the full list of recalled items, including lot numbers, on the FDA’s official recall notice

What Should Consumers Do?

1. Stop Use Immediately: Discontinue using any of the recalled eye care products.
2. Dispose or Return: Throw the products away or return them to the store where purchased for a refund.
3. Complete Recall Forms: Even if you no longer have the product, fill out the “Quantity to Return” section and customer details on AvKARE’s recall form (available on their website). Submit it via email or fax.

AvKARE has advised retailers to remove these items from shelves and quarantine remaining stock.

Understanding Recall Classifications

The FDA uses three recall classes to prioritize risks:

• Class I: High risk of severe harm or death.
• Class II: Possible serious health issues, though the threat is lower.
• Class III: Unlikely to cause harm but violate FDA guidelines.
  
  This eye care recall falls under Class II, highlighting the need for prompt action despite uncertain immediate dangers.
  

Other Recent Recalls to Note

This isn’t the only major recall in 2025. Here are two others that raised alarms:

1. Optimal Carnivore Bone & Joint Restore Capsules:

• Reason: Potential salmonella contamination.
• Risk: Salmonella causes fever, stomach cramps, and diarrhea.
• Impact: 1,500 bottles sold via Amazon and other retailers.
  

2. Henkel’s Tec Italy Totale Shampoo:

• Reason: Possible presence of Klebsiella oxytoca bacteria.
• Risk: Infections in the eyes, nose, or skin.
• Impact: 1,068 bottles recalled in March 2025.
  
  

How to Stay Safe

Recalls often occur after products hit the market, so staying informed is key. Here’s how:

• Sign Up for Alerts: Subscribe to FDA recall emails or follow them on social media.
• Check Labels: Verify lot numbers if a product you use is recalled.
• Report Issues: Contact the FDA’s MedWatch program if you experience side effects.
  
  

Final Thoughts

While no injuries have been reported yet from the eye care products, the FDA and AvKARE stress the importance of caution. “When manufacturing standards aren’t met, we can’t guarantee safety,” AvKARE stated in their release.

If you’ve used these eye drops and notice redness, pain, or vision changes, seek medical help immediately. For refunds or questions, contact AvKARE’s customer service at 1-855-361-3993 or visit their website.

Stay vigilant—your health depends on it!

For updates on recalls, visit : FDA.gov/recalls.

This article simplifies complex information, uses clear headings, and avoids technical jargon to ensure readability. It emphasizes actionable steps for consumers and ties in related recalls to provide context. By linking to official resources and explaining recall classifications, it aims to empower readers with practical knowledge.