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, per the company website.

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.

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. The company says they are “an independent contract testing laboratory” specializing in a variety of areas, including “finished product testing services for the pharmaceutical industry.”

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.

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

Additional product details from the FDA include:

Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants) Lubricant Eye Drops, Sterile

  • 5 FL OZ (15 mL) per dropper bottle
  • Lot and Expiration Dates:
    • Lot 126, exp 10/26/25; Lot 127, exp 10/30/25; Lot 128, exp 11/02/25; Lot 129, exp 11/06/25; Lot 162, exp 5/09/26; Lot 163, exp 5/14/26; Lot 164, exp 5/20/26; Lot 165, exp 5/23/26; Lot 166, exp 5/29/26; Lot 167, exp 6/03/26; Lot 168, exp 6/06/26; Lot 169, exp 6/10/26; Lot 170, exp 6/13/26; Lot 193, exp 10/07/26; Lot 194, exp 10/10/26; Lot 195, exp 10/14/26; Lot 196, exp 10/17/26; Lot 197, exp 10/21/26; Lot 198, exp 10/24/26; Lot 199, exp 10/30/26
  • 13,872 cases (24 cartons per case)

Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel, Sterile

  • 5 FL OZ (15mL) per bottle
  • Lot and Expiration Dates:
    • Lot 114, exp 9/04/25; Lot 115, exp 9/06/25; Lot 116, exp 9/10/25; Lot 207, exp 12/05/26
  • 1,610 cases (24 cartons per case)

Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Carboxymethlycellulose Sodium 0.5% Eye Lubricant, Lubricating Eye Drops, Moisturizing, Sterile

  • 5 FL OZ (15mL) per dropper bottle
  • Lot and Expiration Dates:
    • Lot 103, exp 4/26/25; Lot 104, exp 5/03/25; Lot 108, exp 6/29/25; Lot 109, exp 7/18/25; Lot 110, exp 8/17/25; Lot 111, exp 8/22/25; Lot 112, exp 8/27/25; Lot 113, exp 9/18/25; Lot 125, exp 10/23/25; Lot 130, exp 11/09/25; Lot 131, exp 11/14/25; Lot 132, exp 11/27/25; Lot 133, exp 11/30/25; Lot 134, exp 12/05/25; Lot 135, exp 12/11/25; Lot 136, exp 12/14/25; Lot 137, exp 1/02/26; Lot 139, exp 1/15/26; Lot 140, exp 1/19/26; Lot 141, exp 1/25/26; Lot 151, exp 3/18/26; Lot 152, exp 3/21/26; Lot 153, exp 3/25/26; Lot 154, exp 3/28/26; Lot 155, exp 4/01/26; Lot 156, exp 4/08/26; Lot 157, exp 4/11/26; Lot 160, exp 4/26/26; Lot 180, exp 8/08/26; Lot 181, exp 8/12/26; Lot 182, exp 8/18/26; Lot 183, exp 8/21/26; Lot 184, exp 8/26/26; Lot 185, exp 9/04/26; Lot 186, exp 9/09/26; Lot 187, exp 9/16/26; Lot 188, exp 9/18/26; Lot 189, exp 9/21/26; Lot 190, exp 9/25/26; Lot 191, exp 9/28/26; Lot 192, exp 10/02/26; Lot 208, exp 12/11/26; Lot 209, exp 12/16/26; Lot 212, exp 1/15/27; Lot 213, exp 1/21/27; Lot 214, exp 1/24/27; Lot 215, exp 2/02/27; Lot 216, exp 2/04/27; Lot 224, exp 3/27/27
  • 32,876 cases (24 cartons per case)

Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye Lubricant, Lubricant Eye Drops, Moisturizing, Sterile

  • 5 FL OZ (15mL) per dropper bottle
  • Lot and Expiration Dates:
    • Lot 117, exp 9/20/25; Lot 118, exp 9/25/25; Lot 119, exp 9/27/25; Lot 121, exp 10/05/25; Lot 161, exp 5/01/26; Lot 171, exp 6/18/26; Lot 172, exp 6/24/26; Lot 174, exp 7/01/26; Lot 175, exp 7/08/26; Lot 200, exp 11/05/26; Lot 201, exp 11/10/26; Lot 202, exp 11/13/26; Lot 203, exp 11/18/26; Lot 204, exp 11/21/26; Lot 205, exp 11/25/26; Lot 206, exp 12/02/26; Lot 219, exp 2/24/27; Lot 221, exp 3/02/27; Lot 222, exp 3/05/27
  • 13,104 cases (24 cartons per case)

Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile

  • 5 FL OZ (15mL) per dropper bottle
  • Lot and Expiration Dates:
    • Lot 120, exp 10/02/25; Lot 122, exp 10/09/25; Lot 123, exp 10/12/25; Lot 124, exp 10/16/25; Lot 138, exp 1/08/26; Lot 142, exp 1/29/26; Lot 143, exp 2/01/26; Lot 144, exp 2/07/26; Lot 145, exp 2/12/26; Lot 146, exp 2/15/26; Lot 147, exp 2/21/26; Lot 148, exp 2/27/26; Lot 149, exp 3/04/26; Lot 150, exp 3/11/26; Lot 158, exp 4/15/26; Lot 159, exp 4/22/26; Lot 176, exp 7/24/26; Lot 177, exp 7/28/26; Lot 178, exp 7/31/26; Lot 179, exp 8/05/26
  • 14,333 cases (24 cartons per case)

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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Molly Jasinski
Molly Jasinski has worked as a writer, editor and social media manager for almost 15 years. She previously worked as an editor for the magazine Birds & Blooms. She’s also held other positions at Trusted Media Brands, working on direct-to-consumer books, editing special interest publications, and assisting with digital production and social me...
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Molly Jasinski