According to AvKARE, the distributor, and the Food and Drug Administration (FDA), over 1.8 million cartons of eye drops have been recalled across the United States due to manufacturing issues that may have compromised their sterility.
The recall notices from AvKARE and the FDA did not specify the exact manufacturing issue but noted a “lack of assurance of sterility,” which could result in products of unacceptable quality.
The notices warned that using these eye drops may pose health risks, including serious eye infections that could lead to temporary vision loss or permanent blindness.
In 2023, the CDC reported 50 infections across 11 states linked to eye drops contaminated with antibiotic-resistant bacteria, resulting in one death and several cases of permanent blindness.
Affected Products
The recalled products, distributed between May 26, 2023, and April 21, 2025, are primarily used to relieve dry eye symptoms. They include:
Artificial Tears Ophthalmic Solution
Carboxymethylcellulose Sodium Ophthalmic Gel 1%
Carboxymethylcellulose Sodium Ophthalmic Solution
Lubricant Eye Drops Solution
Polyvinyl Alcohol Ophthalmic Solution
Manufacturing Issues
The FDA identified the manufacturing issues during an audit but did not disclose the manufacturer or specific brands involved.
BRS Analytical Service, LLC, an independent laboratory that tests pharmaceutical products for quality and safety, notified AvKARE, a Tennessee-based healthcare distributor, of the voluntary recall.
AvKARE has urged consumers to immediately stop using the recalled eye drops.
Retailers are instructed to remove the products from their inventory and return them to AvKARE for a full refund, including shipping costs. The company expressed regret for any inconvenience caused by the recall.
Non-sterile eye drops can cause severe eye infections. Dryrolls with antibiotic-resistant bacteria, as seen in the 2023 outbreak, highlight the risks.
Dry eye, a condition these drops treat, causes symptoms like irritation, burning, redness, light sensitivity, mucus, blurred vision, and eye fatigue.
The recall is particularly concerning as allergy season may increase dry eye symptoms, leading to greater reliance on these products.