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Walgreens-branded eye drops recalled over sterility concerns affecting over 500,000 units

More than half a million Walgreens eye-drop bottles are being recalled after a manufacturer flagged sterility doubts, prompting a Class II FDA recall.

Sterling Pharmaceutical Services LLC, based in Dupo, Illinois, initiated a recall of eye-care products on Aug. 20 after identifying a lack of assurance of sterility. The U.S. Food and Drug Administration later designated the recall as Class II, meaning exposure could cause temporary or medically reversible issues, though serious consequences are unlikely. Walgreens-branded eye drops represent more than 500,000 of the recalled units, including about 301,114 single bottles and 199,600 twin packs.

The recall also encompasses over 120,000 packages of AvKare Carboxymethylcellulose Sodium Ophthalmic Solution and various products from Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP The Relief Products and Major. Ophthalmic products require strict sterility because they bypass many of the body’s natural defenses, raising infection risks. A Walgreens spokesperson did not respond to requests for comment.

Why it matters

Consumers using the recalled eye drops could face eye irritation or infection without proper sterility.

In this story

eye dropsrecallsterilityclass IIFDAWalgreensSterling Pharmaceuticalophthalmic productsinfection risk
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