Urgent Nationwide Eye Drops Recall After FDA Audit

Credit: FDA

AvKARE, LLC, in coordination with BRS Analytical Service, LLC, has announced a voluntary nationwide recall of five ophthalmic products at the consumer level, effective May 8, 2025.

The eye drop recall was initiated due to manufacturing deviations from Current Good Manufacturing Practices (cGMP) identified during an FDA audit.

The health risk to users is unknown, but the deviations may result in products of unacceptable quality, and patient risks cannot be ruled out.

The recalled products, shipped between May 26, 2023, and April 21, 2025, include:

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 0.5%

NDC 50268-126-15: Lubricant Eye Drops Solution

NDC 50268-678-15: Polyvinyl Alcohol Ophthalmic Solution

Consumers are urged to immediately stop using these products and check their inventory for the affected lot numbers, which have expiration dates from April 2025 to March 2027.

Customers should complete the “Quantity to Return” section of the recall notice, available on AvKARE’s website, and submit it via email to customerservice@avkare.com or fax to 931-292-6229, even if no product is held.

The recall is being conducted with the FDA‘s knowledge. Consumers with questions can contact AvKARE’s customer service.

For a complete list of affected lot numbers, refer to the recall notice on AvKARE’s website.