RECALL: FDA Uncovers Eyedrop Manufacturing Irregularities And Sterility Concerns

Close-up of a blue eye with intricate patterns.

More than 1.8 million cartons of eye drops have been pulled from US shelves after FDA inspectors discovered troubling manufacturing violations and sterility concerns.

Quick Takes

1.8 million eye drop cartons recalled due to FDA manufacturing violation findings.
The recall affects multiple products, including Artificial Tears.
Consumers must stop using products and can request refunds.
The FDA audit revealed significant deviations from manufacturing standards.

FDA Audit Sparks Major Eye Drop Recall

In a substantial consumer safety measure, AvKARE announced the voluntary recall of several eye care products. The FDA’s recent audit uncovered serious deviations from current good manufacturing practices (cGMP), primarily centered around sterility issues. Although no injuries or illnesses have been reported, “it is not possible to rule out patient risks resulting from use of these products,” the company stated.

The recall involves five key products: Artificial Tears Ophthalmic Solution, Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethylcellulose Sodium Ophthalmic Solution, Lubricant Eye Drops Solution, and Polyvinyl Alcohol Ophthalmic Solution. These products were distributed across the United States from May 26, 2023, through April 21, 2025. Consumers have been urged to stop using the affected products immediately.

Voluntary Recall’s Broad Impact and Consumer Guidance

AvKARE initiated the recall, advising both consumers and healthcare providers to cease the use of these products. The FDA categorized this as a Class II recall, cautioning that the use or exposure to the affected items “may cause temporary or medically reversible adverse health consequences.” Consumers are encouraged to seek medical advice if adverse reactions occur and to return the products for a refund. Full credit for the products, including shipping costs, will be offered.

To facilitate the recall process, AvKARE provides a refund through a recall notice, which consumers need to fill out and submit. Even if the product is not returned, consumers should complete this process. A comprehensive list of affected products, along with expiration dates and product codes, is available on the AvKARE website.

Ensuring Consumer Safety Amid Manufacturing Challenges

The recall represents AvKARE’s response to the serious findings of the FDA audit. By following cGMP regulations, manufacturers ensure drug safety and quality, as emphasized by the FDA: “The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.” Although no specific adverse health outcomes have been linked to these products, the potential risk has mandated this recall action to protect consumers worldwide.

As this situation develops, consumers are urged to follow guidance associated with the recall and contact AvKARE’s customer service with any questions surrounding the issue.