Recall Alert: Over-the-Counter Eye Care Products Linked to FDA Violations

St. Louis, MO – A nationwide recall has been issued for several over-the-counter ophthalmic products following a manufacturing deviation found during a U.S. Food and Drug Administration (FDA) audit. The recalling firm, BRS Analytical Services LLC, announced this voluntary recall through healthcare distributor AvKARE.

The FDA classified the recall due to concerns that the products may not meet acceptable quality standards, potentially posing risks to consumers. The recall notice urged users to stop using the affected products immediately. AvKARE emphasized that while health hazards have not been identified, it is impossible to rule out risks associated with the use of the recalled items.

Distributed between May 26, 2023, and April 21, 2025, the recalled products include various eye drops intended for treating dry eye conditions, which can cause discomfort and vision problems. The affected products were shipped in significant quantities, approximately 1.8 million cartons according to reports.

The manufacturing violations were labeled as cGMP (current Good Manufacturing Practice) deviations. These violations could lead to products of unacceptable quality, AvKARE noted in a statement. Affected consumers are advised to check their inventory for the recalled lots and discontinue use immediately.

For those in possession of the recalled products, the company instructed them to fill out a “Quantity to Return” section on the recall notice and send it via fax to 931-292-6229 or email to [email protected]. AvKARE will provide customers with a “Return Authorization Form” for shipping back the products to receive a full credit, including shipping costs.

As the allergy season approaches, there is increasing use of eye drops, heightening concerns regarding this recall. Users of these products are urged to stay informed and follow the specified guidelines to ensure their safety.