More than 70,000 cases of ophthalmic products are being recalled for manufacturing deviations, according to a press release by distributor AvKARE.

The recalled products, which include eye drops and artificial tears, were distributed nationwide over the course of two years.

Here’s what Illinois consumers should know.

Which products are being recalled?

St. Louis-based firm BRS Analytical Service LLC. notified AvKARE of its Class II voluntary recall in late April. The recall includes the following products:

• 13,872 cases of Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants) Lubricant Eye Drops, STERILE, 0.5 FL OZ (15 mL) per dropper bottle
• 1,610 cases of Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel, Sterile, 0.5 FL OZ (15mL) per bottle
• 32,876 cases of Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Carboxymethlycellulose Sodium 0.5% Eye Lubricant, Lubricating Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle
• 13,104 cases of Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye Lubricant, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle
• 14,333 cases of Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle

Where were the products distributed?

The recalled products were distributed nationwide between May 26, 2023, and April 21, 2025.

Why are the products being recalled?

AvKARE said in its release that the recall was initiated “due to manufacturing cGMP deviations identified during an audit by FDA.”

The distributor said the “health hazard to the user is unknown,” but the deviations “may lead to products of unacceptable quality, and it is not possible to rule out patient risks resulting from use of these products.”

What is a Class II recall?

The FDA defines a Class II recall as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

This is the second most serious type of recall, just under a Class I recall, according to the administration.

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What to do if you believe you have a recalled product

AvKARE requests that those who think they have recalled products complete a “Quantity to Return” form on its website and fax it to 931-292-6229 or email it to customerservice@avkare.com.

The FDA recommends the following additional steps:

• Consumers who display symptoms should contact their healthcare provider. To report a complaint or adverse event, visit Industry and Consumer Assistance.
• Return the recalled product to the store for a full refund or wrap it securely and discard it in the trash.
• Do not distribute recalled products to others or donate them.
• Clean all surfaces that were in contact with the contaminated product.

Taylor Ardrey contributed to this article.