Nationwide Recall Issued for Multiple OTC Eye Care Products

A voluntary recall for multiple OTC eye care products, including artificial tears and lubricant eye drops, was issued due to serious manufacturing violations identified during an FDA audit. The recall, initiated by BRS Analytical Service and distributed by AvKARE of Pulaski, Tennessee, affects approximately 1.8 million cartons of five ophthalmic solutions shipped between May 26, 2023, and April 21, 2025.

A notice posted on the AvKARE website stated, "This recall has been initiated due to manufacturing cGMP deviations identified during an audit by FDA. Health Hazard to the user is unknown, cGMP deviations may lead to products of unacceptable quality, and it is not possible to rule out patient risks resulting from use of these products."  

Further use of the products should immediately cease. The below marketed products are subject to the recall:

• 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

The full inventory list can be found here. Customers should examine inventory for any of these lots, and if found, immediately discontinue use and remove it from active inventory. Comsumers can download this form and complete the  “Quantity to Return” section and the 'Customer information' block below. It can be faxed to 931-292-6229 or emailed to  customerservice@avkare.com.