AvKARE Eye Drop Recall Issued for More Than 1.8 Million Cartons of Optical Lubricants

The recalled eye drops do not comply with the FDA’s current good manufacturing practices, raising concerns that they may be contaminated with bacteria and unsafe for use.

Federal regulators have issued a recall for more than 1.8 million cartons of AvKARE eye drops, citing manufacturing problems that could lead to bacterial contamination and pose potential health risks for users treating dry eye symptoms.

The U.S. Food and Drug Administration (FDA) announced the AvKARE eye drop recall on May 6, warning consumers to immediately stop using the recalled product.

Artificial tears and similar eye drop products are commonly used to lubricate the eyes, relieve dryness, and treat irritation caused by conditions like allergies, redness or environmental factors. These over-the-counter medications help maintain moisture on the eye’s surface and are especially beneficial for individuals with chronic dry eye or those exposed to wind, screens or contact lenses.

Although these household products are usually considered safe, artificial tear recalls have been issued in recent years due to contamination risks. One of the most recent incidents occurred in 2023, when EzriCare Artificial Tears were recalled after being linked to a rare and drug-resistant strain of bacteria.

The EzriCare recall was linked to an outbreak of Pseudomonas aeruginosa, a rare and drug-resistant bacteria that caused dozens of infections across multiple states. Reported injuries included serious eye infections, permanent vision loss, and at least one death from a bloodstream infection.

As a result, consumers nationwide filed EzriCare Artificial Tears lawsuits, including personal injury claims and class actions seeking compensation for those harmed or who purchased the contaminated products before they were recalled in February 2023.

2025 AvKARE Eye Drops Recall

In the latest eye drops recall, AvKARE indicates the company first became aware of the issue after an independent contract testing lab, BRS Analytical Service, LLC, identified violations of Current Good Manufacturing Practice (cGMP) standards during a routine FDA audit.

While the exact health risks remain unknown, the recall notice warns that cGMP deviations can result in products of substandard quality, and potential safety issues, including bacterial contamination, which cannot be ruled out.

The recalled eye drops were distributed nationwide between May 26, 2023 and April 21, 2025, and include the following products identified by their National Drug Codes (NDC):

• 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 

Specific lot numbers and expiration dates can be found in the recall report.

Although the report does not mention any injuries from the products, the FDA has categorized this as a Class II event, meaning the products may cause temporary or medically reversible adverse health effects. 

AvKARE requests that customers who have purchased the recalled product complete the “Quantity to Return” and customer information sections of the recall notice, and fax it to 931-292-6229 or email it to customerservice@avkare.com even if the quantity is zero.

Once the response form is received, AvKARE will issue a Return Authorization (RA) form to facilitate the return of any recalled product, with shipping costs covered.