Eye Drops Recall 2026: Hundreds of thousands of eye-drop bottles and packs sold under brands including Walgreens, AvKare and other names are being recalled in the US over concerns that the products may not be sterile, according to information from the U.S. Food and Drug Administration (FDA).
Sterling Pharmaceutical Services LLC, based in Dupo, Illinois, initiated the recall on August 20, 2026, according to an FDA enforcement report dated the same day. The FDA classified the recall as Class II on September 21, 2026.
The recall covers nine eye-care products and 747,844 units in total, including lubricant eye drops, a hypertonicity ophthalmic solution and a nighttime eye ointment.
Eye Drops Recall 2026: Why Were The Products Recalled?
The recall concerns a lack of assurance that the affected products are sterile, according to the information provided in the FDA enforcement report.
Sterility is particularly important for products intended for use in or around the eyes. Consumers who have products covered by the recall are advised to check the relevant product information before continuing to use them.
Which Eye Drops Are Included In The Recall?
The 2026 eye drops recall covers nine products sold under several brand names. According to the information provided, the affected products and quantities are:
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Cameron Pharmaceuticals Carboxymethylcellulose Sodium 0.5% Eye Lubricant, 0.5 fl oz (15 mL): 19,284 bottles
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AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, 0.5 fluid ounces (15 mL): 12,864 packs
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AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, two-count twin packs: 107,377 packs
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Reliable-1 Laboratories Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, 0.5 fluid ounces (15 mL): 11,083 bottles
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Reliable-1 Laboratories Lubricating Tears, 0.5 fluid ounces (15 mL): 47,616 bottles
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Walgreens Lubricant Eye Drops, Carboxymethylcellulose Sodium 0.5%, 0.5 fluid ounces (15 mL): 301,114 bottles
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Walgreens Lubricant Eye Drops, two-count twin packs: 199,600 packs
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TRP The Relief Products Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%: 14,538 bottles
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Major LubriFresh P.M. Nighttime Ointment, 0.125 ounces (3.5 g): 34,368 tubes
Together, the recalled products account for 747,844 units.
Walgreens Eye Drops Recall: Are Walgreens Products Included?
Yes. The recall includes Walgreens Lubricant Eye Drops containing carboxymethylcellulose sodium 0.5%, both in individual 0.5-fluid-ounce bottles and two-count twin packs.
The individual Walgreens bottles account for 301,114 units, while the two-count twin packs account for 199,600 packs, according to the information provided.
Consumers who have Walgreens-branded eye drops should therefore check the product details against the FDA’s recall information rather than assuming that every product carrying the brand is affected.
AvKare Eye Drops Recall: What Products Are Included?
Two AvKare products are listed in the recall. These include carboxymethylcellulose sodium ophthalmic solution 0.5% lubricant eye drops in 0.5-fluid-ounce bottles, as well as two-count twin packs.
The recall involves 12,864 packs of the single-product packaging and 107,377 packs of the two-count version.
What Does Class II Recall Mean?
The FDA classified the recall as Class II on September 21.
According to the FDA’s definition, a Class II recall involves a situation in which exposure to or use of the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is considered remote.
The classification in this case is connected to the lack of assurance that the recalled products are sterile.
How To Check If Your Eye Drops Are Recalled?
Consumers should not rely only on the brand name when checking whether their eye drops are included in the recall.
The FDA recall information contains specific lot numbers and expiration dates for the affected products. Consumers should compare the following details on their product with the information listed in the FDA Enforcement Report:
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Product name
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Brand
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Lot number
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Expiration date
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Product packaging and size
If the product details match the recalled information, consumers should treat the product as part of the recall.
What Should Consumers Do If They Have Recalled Eye Drops?
According to the information provided, consumers whose products are included in the recall should immediately stop using the eye drops and speak with their doctors.
Consumers should first confirm the product’s lot number and expiration date against the FDA’s recall information. If the product is confirmed as part of the recall, they should not continue using it.
The source information provided does not specify a universal refund or return procedure for the recalled products, so consumers should not assume that a refund is guaranteed solely on the basis of the recall.
Eye Drops Recall 2026: What Consumers Need To Know
The recall affects hundreds of thousands of products across several brands and product types. While the FDA has classified the action as Class II, the key issue identified in the recall is the lack of assurance that the products are sterile.
Consumers who use products from Walgreens, AvKare, Cameron Pharmaceuticals, Reliable-1 Laboratories, TRP The Relief Products or Major should check the specific product information and compare the lot number and expiration date with the FDA’s recall listing. The recall was initiated by Sterling Pharmaceutical Services LLC on August 20, 2026, while the FDA assigned the Class II classification on September 21.
Disclaimer: The information in this article is based on the cited recall information and is intended for general awareness. Consumers should refer to the FDA’s official recall notice and consult a healthcare professional for medical advice or concerns related to use of a recalled product.
