Nearly 750,000 Eye-Care Units Recalled — Over 500,000 Eye Drops, Including Walgreens Brand, Pulled for Sterility Concerns

Sterling Pharmaceutical Services LLC of Dupo, Illinois, has recalled nearly 750,000 eye-care units — more than 500,000 of them eye-drop products — after the company determined it could not guarantee the products' sterility. The recall was initiated on Aug. 20 and was classified by the U.S. Food and Drug Administration as a Class II recall on Sept. 21.

What Was Recalled

The recall affects nine products sold under multiple brand names and distributed by several companies. Key affected items include:

FDA headquarters in MarylandCredit: Alamy

• Walgreens Lubricant Eye Drops: ~301,114 single 0.5 fl oz bottles and ~199,600 two-count packs distributed by Walgreens.
• AvKare: ~12,864 single 0.5 fl oz packs and ~107,377 two-count twin packs of Carboxymethylcellulose Sodium 0.5% lubricant drops.
• Reliable-1 Laboratories: ~11,083 bottles of Sodium Chloride Hypertonicity Ophthalmic Solution (0.5 fl oz, 5%) and ~47,616 bottles of Lubricating Tears (0.5 fl oz).
• Cameron Pharmaceuticals: ~19,284 bottles of Carboxymethylcellulose Sodium 0.5% lubricant drops (0.5 fl oz).
• TRP The Relief Products: ~14,538 bottles of Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose Sodium 0.5%.
• Major: ~34,368 tubes of LubriFresh P.M. Nighttime Ointment (0.125 oz).

Scope and Classification

The FDA's Class II designation means that exposure to a violative product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse effects is remote. The agency is advising consumers to stop using any of the listed products and consult a health care professional if they have concerns.

What Consumers Should Do

• Immediately stop using any eye drops or ointments that match the recalled products' descriptions.
• Check the FDA recall notice for lot numbers and more details to confirm whether your product is included.
• Contact your eye care provider if you experience eye irritation, redness, pain, vision changes, or any other concerning symptoms.
• Contact the retailer or distributor for return or refund instructions as provided in the FDA notice.

Context

This action follows other ophthalmic product recalls earlier in the year, including more than 39,000 bottles of Clear Eyes Maximum Itchy Eye Relief in August and about 2.5 million bottles of prescription eye drops from Lupin Pharmaceuticals in July — both tied to contamination or sterility concerns.

PEOPLE has contacted Sterling Pharmaceutical Services for comment on the current recall.