Over 70,000 Eye Products Recalled in USA After FDA Audit

A voluntary nationwide recall of multiple ophthalmic products was issued on May 12, citing potential safety concerns stemming from serious manufacturing violations. More than 70,000 units of eye care products distributed across the United States are affected.

FDA Cites Manufacturing Violations in Ophthalmic Product Recall

The recall was initiated by BRS Analytical Service, LLC, an independent contract testing laboratory, after identifying possible safety and quality issues related to the manufacturing process. Following an FDA audit, investigators uncovered significant violations of Current Good Manufacturing Practice (CGMP), prompting the recall action.

The U.S. Food and Drug Administration (FDA) classified the issue as a Class II recall, indicating a situation where use of or exposure to the product may lead to temporary or medically reversible adverse health effects, although the likelihood of serious consequences remains low.

List of Recalled Eye Care Products

The recall includes the following five ophthalmic solutions, all of which received Class II recall designation due to manufacturing non-compliance:

       • 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 events or health hazards have been reported, the FDA cautioned that the deviations from CGMP could lead to “products of unacceptable quality,” and risks to patient safety cannot be completely ruled out.

Distribution and Consumer Guidance

All affected products were distributed by AvKARE, based in Pulaski, Tennessee, between May 26, 2023, and April 21, 2025. Consumers in possession of these products are advised to immediately discontinue use and follow instructions for product return.

AvKARE issued the following statement:
“We will issue full credit including shipping cost for any returns.”

Consumers are instructed to complete the “Quantity to Return” section on the official recall notice and send it via email to customerservice@avkare.com or fax to 931-292-6229, regardless of whether they still have the product in their possession.