Over 70,000 units of eye care products have been recalled across the U.S. due to potential safety risks. The U.S. Food and Drug Administration (FDA) classified the recall as Class II—indicating the potential for temporary or medically reversible adverse health effects, though the likelihood of serious consequences is considered low. The recall was initiated following an FDA audit of BRS Analytical Service, LLC, which found breaches in Current Good Manufacturing Practice (CGMP), raising alarms about product quality and patient safety. All affected products were distributed by AvKARE, Inc.*

Recalled Products and Associated Risks

The recall affects five ophthalmic solutions distributed nationwide between May 26, 2023, and April 21, 2025. The FDA identified these products as:

• 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)
  

Although no specific adverse health events have been reported, the failure to meet CGMP standards suggests these products may not be sterile or may contain inconsistent formulations, posing a potential risk to users, particularly those with compromised eye health or immune systems.

Consumer Guidance and Return Instructions

AvKARE urges consumers to stop using the recalled products immediately. All returns will be credited in full, including shipping costs. Even if the product is no longer in the consumer’s possession, they are encouraged to notify the company.

To initiate a return:

• Complete the “Quantity to Return” section on the recall notice.
  
• Email the form to: customerservice@avkare.com, or
  
• Fax it to: 931-292-6229.
  

For additional support or questions regarding the recall, consumers should contact AvKARE’s customer service directly.

Staying informed and taking swift action can help ensure patient safety and product accountability.

*Charters, L. (2025, May 12). Potentially hazardous eye care products recalled nationwide. Ophthalmology Times. https://www.thehealthy.com/news/glaucoma-eye-drops-recall-nationwide/ 

To ensure that we always provide you with high-quality, reliable information, Responsum Health closely vets all sources. We do not, however, endorse or recommend any specific providers, treatments, or products, and the use of a given source does not imply an endorsement of any provider, treatment, medication, procedure, or device discussed within.