A recent nationwide recall has affected more than 1.8 million cartons of eye drops due to potential sterility issues during manufacturing.

The recall was announced by AvKARE, the distributor, alongside a notice from the FDA (Food and Drug Administration).

While the specific details regarding the health risks were not disclosed, the recall was prompted by a lack of sterility assurance that could lead to products of unacceptable quality.

The Risks of Using Unsterilized Eye Drops

Although the recall notice did not explicitly mention any health hazards, improperly sterilized eye drops can be a serious concern.

The FDA and AvKARE’s warning suggests that these products could lead to eye infections, which, in extreme cases, may cause temporary vision loss or even blindness.

A past incident in 2023 highlighted these risks when 50 infections linked to contaminated eye drops were reported across 11 states.

Tragically, one of these cases resulted in a death, and others led to permanent blindness.

Which Products Are Affected?

The eye drops involved in this recall were distributed between May 2023 and April 2025, primarily for relieving dry eye symptoms.

The affected products include:

Artificial Tears Ophthalmic Solution
Carboxymethylcellulose Sodium Ophthalmic Gel 1%
Lubricant Eye Drops Solution
Polyvinyl Alcohol Ophthalmic Solution

All of these products are commonly used for treating dry eyes, which occur when the eyes do not produce enough tears or when the tears they produce are ineffective.

Steps Consumers Should Take

AvKARE, the Pulaski, Tennessee-based healthcare distributor, has urged consumers to stop using the recalled eye drops immediately.

In addition, retail stores should remove the products from their shelves and return them to AvKARE for a full refund, including shipping costs.

AvKARE expressed regret over the inconvenience this may cause, emphasizing their commitment to ensuring the safety of consumers.

Why the Recall Was Issued

The FDA discovered these issues during a routine audit, though the exact manufacturer or brand behind the affected drops has not been disclosed.

The recall was initiated after BRS Analytical Service, an independent testing lab, flagged the problem.

This service tests pharmaceutical products to ensure they meet manufacturing standards before distribution.

Understanding Dry Eye Symptoms

Dry eye is a condition in which the eyes either don’t produce enough tears or the tears they produce don’t work properly.

The condition can cause various symptoms, including:

Irritation (feeling gritty or sandy)
Burning sensation
Redness
Sensitivity to light
Mucus in or around the eyes
Blurred vision
Tired eyes

The Impact of Allergy Season on Eye Health

The recall comes at a particularly concerning time, as allergy season tends to worsen dry eye symptoms.

Pollen-related inflammation can reduce tear production, and medications like antihistamines and decongestants often contribute to dry eyes.

As a result, eye drop sales typically increase in the spring when pollen counts are high.

What the FDA Says About the Severity

This recall is classified as Class II, which means that while the use of the affected drops may cause temporary or reversible health issues, the risk of serious health consequences is considered low.

To date, there have been no reports of health problems linked to these products.

In the meantime, consumers who have purchased the affected drops should follow the recall instructions and seek alternatives to manage their dry eye symptoms.