Nationwide Recall Issued for Eye Care Products Over Quality Concerns

St. Louis, MO — A voluntary recall has been issued for several eye care products in the United States due to manufacturing issues found during an audit by the U.S. Food and Drug Administration (FDA). The recall was classified last week after the FDA notified the recalling firm, BRS Analytical Services LLC, about deviations from good manufacturing practices.

Healthcare distributor AvKARE confirmed it was informed of the recall, which affects a range of lubricant and ophthalmic solutions. The company warned that the manufacturing deviations could lead to products with unacceptable quality, raising concerns about potential patient risks.

The FDA has classified the recall as a Class II, which suggests that exposure to the recalled products may cause temporary health issues or where the probability of serious health effects is low. However, specifics about any health risks associated with the affected products remain unclear.

The recalled items were distributed between May 26, 2023, and April 21, 2025. AvKARE is urging consumers and healthcare providers to immediately stop using the recalled products and check their inventory for the affected lots.

“If you have any of the recalled products in your inventory, please discontinue use and remove it from active stock,” advised AvKARE in a notice on its website. The company also offered to provide full credit, including shipping costs, for returned items.

In a statement, AvKARE expressed regret for any inconvenience this recall may cause to consumers and healthcare providers. It also emphasized the importance of safety for patients using eye care products.

As of now, no injuries or illnesses have been reported from the use of these products, but the FDA’s notice cautioned that the lack of assurance of sterility could pose risks. Consumers with questions about the recall can contact AvKARE for more details.