AvKare recalls over-the-counter eye drops after FDA audit

Pharmaceutical company AvKare has issued a voluntary recall on several of its over-the-counter products for dry and irritated eyes, citing regulatory “deviations” identified during an audit by the Food and Drug Administration.

“Health Hazard to the user is unknown,” AvKare said in a statement on its website. The “deviations may lead to products of unacceptable quality, and it is not possible to rule out patient risks resulting from use of these products.”

These deviations could be anything from issues with packaging to problems that occurred during manufacturing. AvKare did not specify what issues had been identified.

The five recalled products include lubricant eye drops and eye gels, which consumers should immediately cease using, AvKare warned. The items affected were shipped May 26, 2023 through April 21, 2025.

The products are:

• NDC# 50268-043-15 Artificial Tears Ophthalmic Solution
• NDC# 50268-066-15 Carboxymethylcellulose Sodium Ophthalmic Gel 1%
• NDC# 50268-068-15 Carboxymethylcellulose Sodium Ophthalmic Solution
• NDC# 50268-126-15 Lubricant Eye Drops Solution
• NDC# 50268-678-15 Polyvinyl Alcohol Ophthalmic Solution

Neither AvKare nor the FDA responded to NPR’s requests for comment.

AvKare said customers are eligible for a full refund on their affected products, including the cost of shipping the returns.

Over-the-counter eye treatments have made headlines in recent years after a spate of contamination issues affected dozens of brands. Some of the affected products in past recalls included eye drops from national brands like CVS Health, Target and Rite Aid.