AvKare, a U.S.-based pharmaceutical company, has announced a voluntary recall of several of its over-the-counter eye care products after an audit by the Food and Drug Administration (FDA) revealed regulatory deviations. The company issued a warning on its website, stating that the health risks to consumers from using the recalled products are currently unknown, but the deviations could potentially lead to products of “unacceptable quality.”
In its statement, AvKare Eye Drops did not specify the exact nature of the regulatory violations. The term “deviations” could encompass issues related to packaging, production procedures, or other aspects of manufacturing. While no injuries or adverse health outcomes have been reported thus far, the company emphasized that it could not rule out risks to patients. The recall was initiated out of what AvKare described as “an abundance of caution.”
Products Affected and Customer Advisory
The recall affects five types of ophthalmic products, including artificial tears, eye gels, and lubricant eye drops that were distributed between May 26, 2023, and April 21, 2025. The specific items under recall are:
- Artificial Tears Ophthalmic Solution (NDC# 50268-043-15)
- Carboxymethylcellulose Sodium Ophthalmic Gel 1% (NDC# 50268-066-15)
- Carboxymethylcellulose Sodium Ophthalmic Solution (NDC# 50268-068-15)
- Lubricant Eye Drops Solution (NDC# 50268-126-15)
- Polyvinyl Alcohol Ophthalmic Solution (NDC# 50268-678-15)
AvKare has advised consumers to immediately stop using any of the listed products and return them to the place of purchase. The company has offered full refunds, including shipping costs for any returned items. Consumers who believe they may have experienced adverse reactions are encouraged to consult a healthcare provider and report the incident to the FDA.
Neither AvKare Eye Drops nor the FDA has responded to further requests for comment regarding the scope of the recall or the potential health risks associated with continued use of the products.
Industry-Wide Concerns Over Eye Drop Safety
This latest recall adds to a growing list of safety concerns surrounding over-the-counter eye care products. In recent years, contamination issues have led to recalls involving major retailers such as CVS Health, Target, and Rite Aid. These previous incidents raised alarms about quality control across the industry, particularly as reports of infections and even cases of vision loss emerged.
While AvKare eye drops has not been linked to any confirmed injuries, the episode underscores the ongoing scrutiny from federal regulators and the heightened vigilance around eye health products. With demand for affordable eye care continuing to rise, the spotlight remains on manufacturers to ensure rigorous compliance with FDA standards.
Consumers are urged to stay informed about product recalls and to review any eye treatments they may have purchased in recent months.
