Eye Care Products Urgently Recalled – Consumers Advised to Stop Use Due to Potential ‘Health Hazard’

A nationwide voluntary recall has been announced in the U.S. by BRS Analytical Services, citing potential health hazards associated with the affected eye care products. ^[1]

Certain eye care products used as artificial tears, manufactured by the well-known pharmaceutical company AvKARE, were recalled by BRS Analytical Service, LLC following an audit by the FDA that reported faulty manufacturing practices and concerns regarding cGMP (Current Good Manufacturing Practice) violations.

Artificial tears are eye drops commonly used to relieve dry, itchy eyes by keeping them moist and lubricated. A large number of people suffering from ophthalmic conditions rely on these products, and ophthalmologists frequently prescribe them as part of routine eye care.

Which Products Are Affected?

More than 75,000 units of these eye care products have been recalled. Customers who purchased the affected products were asked to complete a form, which included a “Quantity to Return” section along with customer information, and return the products by shipment to the specified address. The company also advised that even if the products had already been used and nothing remained to return, customers should still fill out the form and send it via fax or email.

Additionally, the company stated that a monetary refund would be provided for the purchase, including reimbursement of return shipping costs.

AvKARE has released a list of the five recalled products:

• 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 26, 2023, and April 21, 2025.

Why Is This Serious?

This is a voluntary recall notice issued on May 6, which was carried out with the knowledge of the U.S. Food and Drug Administration (FDA). The recall follows an audit conducted by the FDA and BRS Analytical Service, LLC, which identified concerns regarding the manufacturing methods of the products and violations of ^[2] current Good Manufacturing Practices (cGMP)—a regulatory framework designed to ensure that pharmaceutical products are consistently produced and controlled according to quality standards—leading to potential health hazards. Therefore, it is classified as a ^[3] Class II recall.

What Consumers Need to Know?

This recall is neither the first nor an isolated incident—it reflects a concerning trend of pharmaceutical recalls in the United States, many of which are linked to violations of current Good Manufacturing Practices (cGMP). Such lapses can pose serious public health risks, not only in the United States but also in countries that import pharmaceutical products from the U.S.

Consumers who have purchased or are currently using any of the recalled products are strongly advised to stop using them immediately and consult their healthcare provider for a thorough check-up, even if they have not experienced any adverse effects so far. They should also ask their healthcare provider for a safer alternative, especially if they rely on these products for chronic eye conditions such as dry eye syndrome or irritation.

It is absolutely essential that consumers understand the importance of staying informed, reading product labels carefully, and promptly reporting any unusual side effects.

References:

1. AvKARE. "Recall Notices." Accessed May 16, 2025. https://www.avkare.com/recall.

2. U.S. Food and Drug Administration. "Facts About Current Good Manufacturing Practice (CGMP)." Accessed May 16, 2025. https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practice-cgmp.

3. U.S. Food and Drug Administration. "Recalls, Corrections and Removals (Devices)." Accessed May 16, 2025. https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices.

(Input from various sources)

(Rehash/ Dr. Shubham Halingali/MSM)