Check Your Meds Cabinet – NOW!

Pharmaceutical distributor AvKARE has voluntarily recalled over 1.8 million units of eye care products due to serious manufacturing standard violations discovered during a federal inspection.

At a Glance

  • Over 1.8 million AvKARE eye drop units recalled across the U.S.
  • FDA inspection revealed manufacturing sterility violations
  • Five eye care products affected, distributed from May 2023 to April 2025
  • No injuries reported, but adverse health risks remain possible
  • FDA classifies the recall as Class II due to temporary health risk potential

FDA Flags Major Safety Failures

In a sweeping move to protect consumers, pharmaceutical distributor AvKARE has voluntarily recalled more than 1.8 million units of eye care products after a federal inspection uncovered serious breaches of manufacturing standards. The FDA cited violations of current Good Manufacturing Practices (cGMP), raising red flags over sterility concerns and potential contamination risks. The products in question include five types of commonly used eye drops—ranging from Artificial Tears to Polyvinyl Alcohol Ophthalmic Solution—sold nationwide between May 26, 2023, and April 21, 2025.

Watch a report: Stop Using These Eye Drops Now!

Although no injuries have been officially documented, both the FDA and AvKARE warn that the defective products pose a credible risk to public health. The federal agency classified the recall as Class II, signaling that while serious harm is unlikely, temporary or medically reversible side effects could still occur.

“Unacceptable Quality” Exposes Flaws

The problems stem from deviations in AvKARE’s manufacturing process that “may lead to products of unacceptable quality,” according to the company. Inspectors noted lapses in sterility protocols and product consistency, which could compromise both the safety and effectiveness of the drops. “It is not possible to rule out patient risks resulting from use of these products,” AvKARE acknowledged in its official recall announcement.

Healthcare providers have been instructed to immediately remove the affected items from their inventories. AvKARE, for its part, is urging consumers to stop using the recalled products and return them for a full refund, including shipping. The company has posted a recall submission form on its website to facilitate rapid processing and compensation.

The FDA emphasized that manufacturing regulations are critical to ensuring pharmaceutical safety: “The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.”

Public Scrutiny and Next Steps

Public concern has escalated in response to widespread media coverage and viral social media warnings, such as one tweet that read, “Check your medicine cabinet now—your eye drops might be on the list.” Videos like “Millions of Eye Drops Recalled—Could Cause Blindness!” have added urgency to the public reaction.

While the recall may prevent harm for now, it casts a harsh spotlight on oversight lapses in pharmaceutical manufacturing. AvKARE has pledged full cooperation with FDA investigators and vowed to tighten its production protocols moving forward.

Still, this incident serves as a wake-up call. The safety net protecting over-the-counter health products is only as strong as the manufacturers who follow the rules—and the regulators who enforce them.