"Eye Drops Recall Alert: 1.8 Million Products Nationwide"

Massive Recall of Eye Drop Products Nationwide

Allergy season is officially here, not that you probably needed the reminder from us. If your eyes have been itchy and watery recently, it’s quite possible pollen is to blame. But for more than 16 million Americans, red eyes and that stinging, burning sensation may actually be a sign of dry eye, according to the National Eye Institute.

Relief for this condition often comes in the form of eye drops, but a massive new recall could affect your favorite solution for soothing those irritated eyes.

The U.S. Food and Drug Administration (FDA) has announced the nationwide recall of 1,819,080 total cartons of eye drops, all of which appear to be for alleviating dry eye symptoms. The distributor is listed as AvKARE in Pulaski, Tennessee, which is a healthcare distributor for both pharmaceuticals and infection control products.

AvKARE says they’re also a supplier for several U.S. governmental entities, including the FDA, Health and Human Services (HHS), and Department of Defense (DoD), as well as “state and local departments.”

It is not clear from the FDA’s report who manufactured the recalled eye drops or if they’re marked with a particular brand name.

Recall Details and Product Information

There’s also a notice concerning the recall posted on the AvKARE website, listing the following products with their National Drug Code (NDC):

• 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

AvKARE’s notice says BRS Analytical Service, LLC. notified them of the voluntary recall on a consumer level due to “manufacturing cGMP deviations identified during an audit by FDA.”

BRS Analytical Services, LLC of St. Louis, Missouri is also identified as the recalling firm in the FDA’s report.

AvKARE’s recall notice goes on to warn: “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.”

The FDA slightly expands on the details around the recall’s cause, listing “cGMP deviations and lack of assurance of sterility.” Current Good Manufacturing Practice, or CGMP, “assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations,” says the FDA.

Product Details and Instructions for Users

AvKARE’s notice says the affected eye drops were “first shipped May 26, 2023, until April 21, 2025.”

Though the recall is nationwide, further details are not provided regarding where consumers may have first received the products. The FDA has categorized the recall as a Class II event, meaning the products “may cause temporary or medically reversible adverse health effects.”

Dry eye occurs when the eyes either don’t produce enough tears to keep the eye properly wet, or the available tears don’t work properly, according to the National Eye Institute. Beyond the irritating feeling, dry eye can also be linked to vision problems for some.

“Further use of this product should immediately cease,” cautions AvKARE. Additional information regarding returning the affected products can be found at the above AvKARE notice link.

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