More Than 75,000 Eye Care Products Recalled Nationwide Over Manufacturing Violations

The health hazard to users is currently unknown, but cGMP deviations can result in products of unacceptable quality, and it is not possible to rule out patient risks resulting from their use.

NTD Newsroom

Published: 5/14/2025, 5:24:24 PM EDT

More Than 75,000 Eye Care Products Recalled Nationwide Over Manufacturing Violations — A woman applies eye drops in a stock photo. (Kim Kuperkova/Shutterstock)

Over 75,000 units of eye care products distributed across the United States have been voluntarily recalled by pharmaceutical consulting firm BRS Analytical Services due to manufacturing violations that could compromise product quality, according to a recall notice.

Medical manufacturer AvKARE said in its recall notice that the recall was initiated after an audit by the U.S. Food and Drug Administration (FDA) identified deviations from current Good Manufacturing Practices (cGMP), raising concerns about the safety and effectiveness of the affected products.

The recall covers multiple ophthalmic solutions and gels including: Artificial Tears Ophthalmic Solution, Carboxymethylcellulose Sodium Ophthalmic Gel 1 percent, Carboxymethylcellulose Sodium Ophthalmic Solution, Lubricant Eye Drops Solution, and Polyvinyl Alcohol Ophthalmic Solution. These products were shipped between May 26, 2023, and April 21, 2025.

According to the recall notice, the health hazard to users is currently unknown, but cGMP deviations can result in products of unacceptable quality, and it is not possible to rule out patient risks resulting from their use.

The company instructed customers and health care providers to immediately stop using the affected products and return any remaining inventory. The recall is being conducted with the knowledge of the FDA, which issued its own recall notice.

Current Good Manufacturing Practices are a set of regulations enforced by agencies such as the FDA to ensure that products are produced consistently and controlled according to quality standards. These guidelines cover every aspect of the manufacturing process, including facility design, equipment calibration, staff training, production controls, and documentation. The goal is to prevent contamination, production errors, and other issues that could lead to unsafe or ineffective products.

Non-compliance with cGMP regulations can have serious consequences, including product recalls, fines, and legal action, according to the Center for Professional Innovation & Education. For example, inadequate training and poor documentation have previously led to major enforcement actions and product recalls in the pharmaceutical industry.

According to AvKARE, customers are asked to complete a return form and send any recalled products to R&S Northeast LLC in Fountain Run, Kentucky. Full credit, including shipping costs, will be provided for returned items. The company said it regrets any inconvenience caused by the recall and encouraged anyone with questions to contact their customer service department.

This recall comes amid a series of recent product recalls in the United States, including food items linked to allergen and contamination concerns. On Saturday, the FDA said in a press release that it is investigating a multistate listeria outbreak tied to ready-to-eat foods produced by a California company, which has resulted in at least 10 hospitalizations in California and Nevada.

The affected products, sold under the brand names Fresh & Ready Foods, City Point Market Fresh Food to Go, and Fresh Take Crave Away, are marked with “use by” dates from April 22 to May 19, 2025.

Earlier this month on May 5, the FDA published an announcement by Tennessee-based Vietti Food Group stating that the company is recalling 4,515 cases of 15 oz. Yellowstone Brown Sugar Molasses Baked Beans across multiple states “due to the presence of undeclared soy.”

“Individuals with an allergy or severe sensitivity to soy risk serious or life-threatening allergic reactions if they consume this product,” the company said.