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More than 500,000 Walgreens brand eye drop products are being recalled for sterility concerns as part of a broader recall involving nearly 750,000 eye care products.
Sterling Pharmaceutical Services LLC, based in Dupo, Illinois, initiated the recall on Aug. 20 due to a “lack of assurance of sterility,” according to an enforcement report from the U.S. Food and Drug Administration (FDA).
The FDA classified the recall as Class II on September 21. This designation means that use of or exposure to the affected products may result in temporary or medically reversible health consequences, while the likelihood of serious health consequences is considered low.
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More than 500,000 Walgreens brand eye drops products are recalled. (Justin Sullivan/Getty Images, File/Getty Images)
Walgreens brand products account for more than 500,000 units in the recall, including approximately 301,114 bottles of Walgreens Lubricating Eye Drops and 199,600 twin packs.
The broader recall also includes eye care products distributed under the brands AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP The Relief Products and Major.
More than 120,000 packages of AvKare Carboxymethyl Cellulose Sodium Ophthalmic Solution 0.5% Lubricating Eye Drops are affected, including individual bottles and twin packages.
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Walgreens Lubricating Eye Drops are among the eye care products recalled due to sterility concerns. (Getty Images/Getty Images)
Products distributed by Reliable-1 Laboratories include 5% Sodium Chloride Hypertonus Ophthalmic Solution and Lubricating Tears.
The recall also includes Cameron Pharmaceuticals Carboxymethyl Cellulose Sodium 0.5% Lubricating Eye Drops, The Relief Products Gentle Eyes TRP Lubricating Eye Drops, and Major LubriFresh PM Nighttime Ointment.
Pedestrians walk past a Walgreens store in downtown Chicago. (Christopher Dilts/Bloomberg via Getty Images, file/Getty Images)
The FDA says ophthalmic products pose an increased risk because medications applied to the eyes bypass some of the body’s natural defenses. The agency says eye drops must be sterile to reduce the risk of infection.
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A representative for Walgreens did not immediately respond to FOX Business’ request for comment.
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