Eye drop recall: Nearly 76,000 cases of eye care products are feared to be of ‘unacceptable quality’

If you’re a frequent eye drop user, now’s the time to check your medicine cabinet: The pharmaceutical lab BRS Analytical Service, LLC has issued a voluntary recall of five different ophthalmic solutions, including some eye drops and artificial tears, due to concerns that the products may be of “unacceptable quality.” Here’s what to know:

What is the reason for the recall?

According to a notice published by the distributor AvKare, the recall was initiated when a U.S. Food and Drug Administration (FDA) audit found “manufacturing cGMP deviations” in the production of the five eye products. CGMP, or Current Good Manufacturing Practice, refers to the required manufacturing process guidelines set by the FDA for a certain item. 

Per the AvKare notice, “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.”

Separately, an FDA enforcement report surrounding the five products notes that there was a “lack of assurance of sterility” found during the agency’s audit. 

BRS Analytical Service voluntarily initiated the five recalls on April 23. On May 6, the FDA classified each as a Class II, meaning it is considered a situation in which exposure to the product may cause “reversible adverse health consequences,” or where the probability of serious health consequences is “remote.”

Which products are being recalled?

The recall encompasses five products, totaling over 75,000 cases of ophthalmic solution, shipped over a two-year period: May 26, 2023, to April 21, 2025.

The products include:

• NDC# 50268-043-15 Artificial Tears Ophthalmic Solution; recall number D-0404-2025
• NDC# 50268-066-15 Carboxymethylcellulose Sodium Ophthalmic Gel 1%; recall number D-0405-2025
• NDC# 50268-068-15 Carboxymethylcellulose Sodium Ophthalmic Solution; recall number D-0406-2025
• NDC# 50268-126-15 Lubricant Eye Drops Solution; recall number D-0407-2025
• NDC# 50268-678-15 Polyvinyl Alcohol Ophthalmic Solution; recall number D-0408-2025

Detailed lots numbers and specific expiration dates can be found here.

Where were the products sold?

According to the FDA, the items were distributed nationwide in the U.S., though specific states and stores were not listed.

What should I do if I have one of the recalled products?

If you have a recalled eye solution, do not use it. Instead, AvKare requests that you follow the instructions listed in its notice to alert the company that you received the recalled product, and then ship the affected items back to its headquarters. 

With any follow-up questions, AvKare’s customer service email is customerservice@avkare.com.

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